FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K842382 |
08/10/1984 |
3M RAPIDSTAT LIGATING CLIP SYS |
3M COMPANY |
|
K842044 |
08/10/1984 |
SARNS EVACUPLEGE CATHETER |
3M HEALTH CARE, SARNS |
|
K842522 |
08/02/1984 |
PDA SYSTEM |
ABBOTT LABORATORIES |
|
K842280 |
08/16/1984 |
TDX DIGITOXIN |
ABBOTT LABORATORIES |
|
K842713 |
08/29/1984 |
TDX DISOPYRAMIDE |
ABBOTT LABORATORIES |
|
K842320 |
08/15/1984 |
TDX REA CHOLESTEROL |
ABBOTT LABORATORIES |
|
K842505 |
08/07/1984 |
TDX REA IRON DIAGNOSTIC KIT |
ABBOTT LABORATORIES |
|
K841362 |
08/02/1984 |
TIDAL DISTENSION IRRIGATION SET |
ABBOTT LABORATORIES |
|
K843016 |
08/17/1984 |
VINYL EXAM GLOVES, NON-STERILE |
ABCO DEALERS, INC. |
|
K843175 |
08/20/1984 |
NERVE STIMULATOR Q10 |
ACM SYSTEMS |
|
K841735 |
08/02/1984 |
ACU-DERM TRANSPARENT INCISE DRAPE |
ACME UNITED CORP. |
|
K842064 |
08/15/1984 |
ACU-DERM TRANSPARENT IV DRESSING |
ACME UNITED CORP. |
|
K842186 |
08/24/1984 |
ACU-DERM TRANSPARENT WOUND DRESSING |
ACME UNITED CORP. |
|
K841723 |
08/01/1984 |
ADLER CUSTOM PROCEDURE PACKS |
ADLER INSTRUMENT CO. |
|
K842670 |
08/08/1984 |
BIOLAS YAG 100 |
ADVANCED BIOMEDICAL INSTRUMENTS |
|
K842556 |
08/10/1984 |
ADVANCED CARDIOVASCULAR BALLOON DILATA |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
|
K842104 |
08/10/1984 |
TOYO JOZO G-GTP TEST |
ADVOCACY INTERNATIONAL, LTD. |
RICHARD T NEY |
K842103 |
08/12/1984 |
TOYO JOZO URIC ACID TEST |
ADVOCACY INTERNATIONAL, LTD. |
RICHARD T NEY |
K842321 |
08/03/1984 |
AIR SHIELDS AS461 MONITORING SYS |
AIR-SHIELDS, INC. |
|
K842554 |
08/12/1984 |
IMMPULSE CORTISOL ASSAY REAGENTS |
AKTIS CORP. |
|
K842571 |
08/16/1984 |
IMMPULSE DIGOXIN ASSAY REAGENTS |
AKTIS CORP. |
|
K842953 |
08/21/1984 |
ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL |
ALL-HANDS MEDICAL SUPPLY, INC. |
|
K842545 |
08/01/1984 |
ALL-HANDS STERILE FIELD-0201 |
ALL-HANDS MEDICAL SUPPLY, INC. |
|
K842969 |
08/28/1984 |
ALLERGENETICS ALLER-SPECIFIC IGE SERUM |
ALLERGENETICS |
|
K842970 |
08/29/1984 |
ALLERGENTICS TOTAL IGE/THEOPHYLLINE |
ALLERGENETICS |
|
K842430 |
08/02/1984 |
ALLIED ASSOC. THERAP. EXERCISE EQUIP |
ALLIED ASSOCIATES, INC. |
|
K842431 |
08/01/1984 |
ALLIED ASSOC. THERAP. EXERCISE EQUIP- |
ALLIED ASSOCIATES, INC. |
|
K842429 |
08/02/1984 |
ALLIED ASSOC. THERAPEUTIC EXER EQUIP- |
ALLIED ASSOCIATES, INC. |
|
K842428 |
08/01/1984 |
ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP |
ALLIED ASSOCIATES, INC. |
|
K842433 |
08/02/1984 |
ALLIED ASSOC. THERAPEUTIC EXERCISE |
ALLIED ASSOCIATES, INC. |
|
K842427 |
08/01/1984 |
ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP |
ALLIED ASSOCIATES, INC. |
|
K842426 |
08/01/1984 |
ALLIED ASSOC. THERAPEUTIC EXERICSE |
ALLIED ASSOCIATES, INC. |
|
K842425 |
08/01/1984 |
ALLIED ASSOCIATES THERAPEUTIC EXERCISE |
ALLIED ASSOCIATES, INC. |
|
K842432 |
08/01/1984 |
ALLIED ASSOCIATES THERAPEUTIC EXERSIE |
ALLIED ASSOCIATES, INC. |
|
K841938 |
08/03/1984 |
CARDIOPLEGIA RESERVOIR CAS-2000 |
AMERICAN BENTLEY |
|
K842620 |
08/27/1984 |
CARDIOTOMY RESERVOIR W/FILTER BCR-3500 |
AMERICAN BENTLEY |
|
K841476 |
08/03/1984 |
TUBULAR HOLLOW FIBER MEMBRANE |
AMERICAN BENTLEY |
|
K842455 |
08/16/1984 |
AMER. BIO-SCIENCE LAB CORTISOL REAGENT |
AMERICAN BIO-SCIENCE LABORATORIES |
|
K842590 |
08/10/1984 |
AMER. BIO-SCIENCE LAB T3 REAGENTS |
AMERICAN BIO-SCIENCE LABORATORIES |
|
K842323 |
08/17/1984 |
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR |
AMERICAN EDWARDS LABORATORIES |
|
K841607 |
08/18/1984 |
AMERICAN EDWARDS LABS FLEXISCOPE |
AMERICAN EDWARDS LABORATORIES |
|
K842798 |
08/10/1984 |
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH |
AMERICAN EDWARDS LABORATORIES |
|
K842799 |
08/10/1984 |
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH |
AMERICAN EDWARDS LABORATORIES |
|
K834429 |
08/10/1984 |
PERIPHERAL DILATATION ANGIOPLASTY-CATH |
AMERICAN EDWARDS LABORATORIES |
|
K842250 |
08/15/1984 |
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE |
AMERICAN MEDICAL OPTICS |
|
K842251 |
08/15/1984 |
AMERI. MEDICAL OPTICS ARGON LASER PHOTO |
AMERICAN MEDICAL OPTICS |
|
K842128 |
08/07/1984 |
AMERICAN MEDICAL OPTICS PHOTOKERATO |
AMERICAN MEDICAL OPTICS |
|
K842542 |
08/20/1984 |
AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
K842860 |
08/30/1984 |
AMERICAN PHARMASEAL I.V. START KIT |
AMERICAN PHARMASEAL DIV. AHSC |
|
K842896 |
08/17/1984 |
BLOM-SINGER LOW PRESSURE VOICE PROSTHES |
AMERICAN V. MUELLER |
|
K842482 |
08/10/1984 |
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT |
AMERSHAM CORP. |
|
K842526 |
08/28/1984 |
AMIZYME-LEISHMANIA SPP. TEST KIT |
AMICO LAB, INC. |
|
K842664 |
08/28/1984 |
ANTI-TOXOPLASMA GONDII KIT |
AMICO LAB, INC. |
|
K841561 |
08/30/1984 |
HESUNG'S BLOOD DONOR SETS |
AMKOR TRADING CO. |
|
K842453 |
08/02/1984 |
DISPOSABLE PREPING PAD |
ANAGO, INC. |
|
K842438 |
08/02/1984 |
DISPOSABLE SURGERY HOOD |
ANAGO, INC. |
|
K842839 |
08/23/1984 |
SERIMM SURE ASO-CHEK CONTROL SERUM |
ANALYTICAL PRODUCTS, INC. |
|
K842852 |
08/03/1984 |
BRAIN HEART INFUSION BROTH |
ANAROBE SYSTEMS |
|
K842855 |
08/03/1984 |
CHRISTENSEN'S UREA AGAR |
ANAROBE SYSTEMS |
|
K842853 |
08/03/1984 |
LYSINE IRON AGAR |
ANAROBE SYSTEMS |
|
K842854 |
08/17/1984 |
MUELLER HINTON BROTH |
ANAROBE SYSTEMS |
|
K842851 |
08/07/1984 |
ORNITHINE INDOLE MOTILITY |
ANAROBE SYSTEMS |
|
K842850 |
08/17/1984 |
TRIPLE SUGAR IRON |
ANAROBE SYSTEMS |
|
K842849 |
08/03/1984 |
TRYPTICASE SOY BROTH |
ANAROBE SYSTEMS |
|
K842862 |
08/28/1984 |
CB FORMALIN |
ANATECH, LTD. |
|
K842940 |
08/28/1984 |
CBA FORMALIN |
ANATECH, LTD. |
|
K842861 |
08/21/1984 |
PRO-PAR CLEARANT |
ANATECH, LTD. |
|
K842863 |
08/21/1984 |
PRO-SOFT DEHYDRANT |
ANATECH, LTD. |
|
K842986 |
08/21/1984 |
REFRAX MOUNTING MEDIUM |
ANATECH, LTD. |
|
K842987 |
08/02/1984 |
APOLLO AIR FLUIDIZED BED |
APOLLO FLUID DYNAMICS |
|
K842707 |
08/21/1984 |
ADP NDNA IFA TEST |
APPLE DIAGNOSTIC PRODUCTS |
|
K840904 |
08/16/1984 |
ACCU-CULT FECAL OCCULT BLOOD TEST |
APPLIED MEDICAL DEVICES, INC. |
|
K843114 |
08/08/1984 |
AMPCO PROCEDURE TRAYS / PACKS |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K841095 |
08/24/1984 |
BP800, 850 1000 |
ASSOCIATED MILLS, INC. |
|
K843102 |
08/17/1984 |
AVA-NEB NEBULIZER |
AVATRON, INC. |
|
K842084 |
08/01/1984 |
AXIOM FEMORAL VENUS CATHETER |
AXIOM MEDICAL, INC. |
|
K841574 |
08/15/1984 |
QUAZAR ESOPHAGEAL STETHOSCOPE |
AXIOM MEDICAL, INC. |
|
K842442 |
08/16/1984 |
AXIOM STABLE II URIC ACID TEST |
AXIOM, INC. |
|
K833365 |
08/22/1984 |
ULTRA SHAPE CONDOMS |
BARNETTS, INC. |
|
K842330 |
08/02/1984 |
AMER. HISTO-ID SYS PRIMARY IGA 2720-21 |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842329 |
08/02/1984 |
AMER. HISTO-ID SYS PRIMARY IGG S7920-11 |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842327 |
08/02/1984 |
AMER. HISTO-ID SYS PRIMARY IGM S7920-31 |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842326 |
08/02/1984 |
AMER. HISTO-ID SYS PRIMARY KIT |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842328 |
08/03/1984 |
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842834 |
08/28/1984 |
HEP-2 CELLS |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842833 |
08/28/1984 |
PMK PRIMARY MONKEY KIDNEY-CELLS |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842253 |
08/23/1984 |
AUGMENTIN 30 MCG SENSI DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K842365 |
08/16/1984 |
CORTI-COTE CORTISOL SOLID PHASE RADIO |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K842891 |
08/22/1984 |
QCA TRIGLYCERIDES |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K842588 |
08/10/1984 |
SIMULTROPIN RADIOIMMUNOASSAY KIT LH |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K842655 |
08/16/1984 |
EPSILON DIGOXIN TEST KIT |
BECKMAN INSTRUMENTS, INC. |
|
K842434 |
08/23/1984 |
BEHING THE EAR HEARING AID T-98 |
BERNAFON, INC. |
|
K840406 |
08/20/1984 |
MICROSURGICAL CO2 LASER SYS - 4100 |
BIO QUANTUM TECHNOLOGIES, INC. |
|
K842490 |
08/17/1984 |
SKIN SCRUB TRAY STERILE SKIN SCRUB KIT |
BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES |
|
K842555 |
08/07/1984 |
DHEA-S DIRECT RIA KIT |
BIOTECX LABORATORIES, INC. |
|
K841635 |
08/03/1984 |
LEPTOS |
BIOTRONIK SALES, INC. |
|
K841633 |
08/06/1984 |
NEOS LP |
BIOTRONIK SALES, INC. |
|
K843221 |
08/24/1984 |
MEGASON MODEL 150 |
BIRTCHER CORP. |
|
K842393 |
08/16/1984 |
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE |
BOEHRINGER MANNHEIM CORP. |
|
K843088 |
08/29/1984 |
EBA 3 S CENTRIFUGE |
BOEHRINGER MANNHEIM CORP. |
|
K843087 |
08/29/1984 |
UNIVERSAL 2 S CENTRIFUGE |
BOEHRINGER MANNHEIM CORP. |
|
K841813 |
08/10/1984 |
TISSUE INTEGRATED PROSTHESIS DRILL |
BOFORS NOBELPHARMA, INC. |
|
K842800 |
08/02/1984 |
MONTG. LARYNGEAL KEEL |
BOSTON MEDICAL PRODUCTS, INC. |
|
K841295 |
08/08/1984 |
HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS |
BOW/PARM |
|
K840440 |
08/03/1984 |
ELECTROCARDIOGRAPH E-340 |
BURDICK CORP. |
|
K842753 |
08/15/1984 |
OXYGEN CONCENTRATOR |
BV MEDICAL EQUIPMENT CO. |
|
K842005 |
08/03/1984 |
MODEL 110-5 & 140-8 |
CAMINO LABORATORIES, INC. |
|
K842614 |
08/08/1984 |
CAROLINA X-RAY CO. SIMPLAFLOAT TABLE |
CAROLINA X-RAY CO., INC. |
|
K842536 |
08/17/1984 |
CDX80 |
CDX CORP. |
|
K842007 |
08/03/1984 |
CENTRIMED SYSTEM 1 |
CENTRIMED CORP. |
|
K842968 |
08/29/1984 |
CHAD ADJUSTABLE CANNULA |
CHAD THERAPEUTICS, INC. |
|
K842824 |
08/02/1984 |
CHERMEL BONE CHISELS |
CHER MEL CORP. |
|
K842822 |
08/02/1984 |
CHERMEL BONE GOUGES |
CHER MEL CORP. |
|
K842823 |
08/02/1984 |
CHERMEL OSTEOTOMES |
CHER MEL CORP. |
|
K842459 |
08/15/1984 |
SITE GILLS STYLE I/A HANDPIECE |
CHIRON VISION CORP. |
|
K842458 |
08/15/1984 |
SITE SIMCOE STYLE I/A HANDPIECE |
CHIRON VISION CORP. |
|
K842540 |
08/08/1984 |
CLINICOMP R.C.I. |
CLINICOMP, INC. |
|
K842054 |
08/02/1984 |
COBE AEPS |
COBE LABORATORIES, INC. |
|
K842138 |
08/03/1984 |
COBE EMERGENCY POWER SOURCE 43610-000 |
COBE LABORATORIES, INC. |
|
K841964 |
08/21/1984 |
MICRO DELTA & CELTAPRO |
COMPUTER DESIGN & APPLICATIONS, INC. |
|
K843213 |
08/24/1984 |
QUALINE WHEELCHAIR PRODUCTS |
CONTEMPORARY HEALTH SYS |
|
K842396 |
08/08/1984 |
ACCUSEAL LEG BAGS & EXTENSION TUBES |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
K841287 |
08/20/1984 |
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
K842395 |
08/08/1984 |
SUR-FIT NIGHT DRAINAGE CONTAINER SET |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
K842397 |
08/08/1984 |
URIHESIVE SYS MALE EXTERNAL CATHETER |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
K842581 |
08/03/1984 |
CAVI-MED |
COOPER LASERSONICS, INC. |
|
K841869 |
08/08/1984 |
COOPER LASERSONICS, 8000 ND.YAGLASER |
COOPER LASERSONICS, INC. |
|
K842257 |
08/08/1984 |
CORPAK URINARY DRAINAGE BAG |
CORPAK CO. |
|
K841893 |
08/30/1984 |
MAXAMAN |
CRYO2 CORP. |
|
K842704 |
08/01/1984 |
MT-700 MT-750 FT-350 |
CRYOMEDICS, INC. |
|
K840096 |
08/02/1984 |
SEBUTAPE |
CUDERM CORP. |
|
K842782 |
08/17/1984 |
PHYSIOLOGICAL ANALYZER CM-710 |
CYBERMEDIC, INC. |
|
K842204 |
08/10/1984 |
DMI ASPIRATOR 500 |
DEAN MEDICAL INSTRUMENTS, INC. |
|
K842551 |
08/02/1984 |
BASE METAL ALLOY |
DENTSPLY INTL. |
|
K840652 |
08/02/1984 |
PRISM-FINE |
DENTSPLY INTL. |
|
K842139 |
08/27/1984 |
THE DENVER PLEURAL-PERITONEAL SHUNT |
DENVER BIOMEDICALS, INC. |
|
K842645 |
08/27/1984 |
CARDIAC SUPPLY TRAY |
DEROYAL INDUSTRIES, INC. |
SUSAN HEVEY |
K842160 |
08/17/1984 |
CHOLESTEROL ASSSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842159 |
08/16/1984 |
CREATININE ASSAY KIT-KINETIC OR ENDPOINT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K843029 |
08/27/1984 |
HIGH DENSITY LIPOPROTEIN PRECIPITATIN |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K843030 |
08/27/1984 |
INORGANIC PHOSPHORUS ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K843031 |
08/27/1984 |
MAGNESIUM ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842155 |
08/07/1984 |
SERUM IRON & SERUM IRON BINDING CAPACI |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842156 |
08/07/1984 |
SERUM IRON & SERUM IRON BINDING CAPACITY |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K843028 |
08/27/1984 |
TOTAL PROTEIN ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K843057 |
08/27/1984 |
UREA ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842606 |
08/17/1984 |
COAT-A-COUNT DHEA RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K842552 |
08/17/1984 |
COAT-A-COUNT DHEA-SO4 RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K842578 |
08/12/1984 |
SOPHEIA/MP DIGITOXIN EIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K842249 |
08/15/1984 |
ACTH NORMAL RANGE |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
|
K842099 |
08/17/1984 |
ACTH STANDARD MATRIX |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
|
K842140 |
08/16/1984 |
PICOSCAL BLOOD CELL COUNTER PS-4 |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K840414 |
08/15/1984 |
COLOR OPTIC CORNEAL EYE SHIELD |
DIVERSATIONS, INC. |
|
K842375 |
08/10/1984 |
VENOUS CANNULA W/BENT, TIP WIRE |
DLP, INC. |
|
K842701 |
08/02/1984 |
HOPPENSTEIN MICROSURGICAL SPINAL INSTRU |
DOWNS SURGICAL LTD. |
|
K842699 |
08/02/1984 |
ISLAM BONE MARROW ASPIRATION NEEDLES |
DOWNS SURGICAL LTD. |
|
K842697 |
08/07/1984 |
ROOTMAN ORBITAL SURGERY INSTRUMENT SET |
DOWNS SURGICAL LTD. |
|
K842702 |
08/02/1984 |
ROSENBERG SKIN GRAFTING KNIVES |
DOWNS SURGICAL LTD. |
|
K842728 |
08/03/1984 |
BUF-FIX |
E K IND., INC. |
|
K842726 |
08/03/1984 |
DECALCIFIER SOLUTION |
E K IND., INC. |
|
K842729 |
08/03/1984 |
DECOLORIZING FLUID |
E K IND., INC. |
|
K842740 |
08/17/1984 |
DELAFIELD HEMATOXYLIN STAIN |
E K IND., INC. |
|
K842730 |
08/03/1984 |
GENTIAN VIOLET |
E K IND., INC. |
|
K842742 |
08/15/1984 |
GIEMSA STAIN |
E K IND., INC. |
|
K842741 |
08/15/1984 |
GILL HEMATOXYLIN STAIN |
E K IND., INC. |
|
K842733 |
08/10/1984 |
GRAM IODINE |
E K IND., INC. |
|
K842721 |
08/03/1984 |
LIMONENE |
E K IND., INC. |
|
K842743 |
08/12/1984 |
NEW METHYLENE BLUE N |
E K IND., INC. |
|
K842738 |
08/17/1984 |
PAP STAIN EA-50 |
E K IND., INC. |
|
K842736 |
08/17/1984 |
PAP STAIN, OG-6 |
E K IND., INC. |
|
K842734 |
08/17/1984 |
SAFRANIN STAIN |
E K IND., INC. |
|
K842724 |
08/03/1984 |
SALINE 0.85% W/O PRESERVATIVE |
E K IND., INC. |
|
K842725 |
08/03/1984 |
SALINE, 0.85%W/PRESERVATIVE |
E K IND., INC. |
|
K842723 |
08/03/1984 |
SALINE, 1.3% W/O PRESERVATIVE |
E K IND., INC. |
|
K842915 |
08/10/1984 |
SULFOSALICYLIC ACID, 3% W/V |
E K IND., INC. |
|
K842727 |
08/03/1984 |
SUPERMOUNT |
E K IND., INC. |
|
K842744 |
08/12/1984 |
WRIGHT STAIN |
E K IND., INC. |
|
K842745 |
08/10/1984 |
WRIGHT-GIEMSA QUICK STAIN |
E K IND., INC. |
|
K842732 |
08/03/1984 |
ZENKERS SOLUTION |
E K IND., INC. |
|
K842548 |
08/16/1984 |
ACA ACETAMINOPHEN ANALYTICAL TEST PACK |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K842549 |
08/16/1984 |
ACA ACETAMINOPHEN CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K842386 |
08/15/1984 |
ACA BARBITURATES SCREEN/BENZODIAZEPIN |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K842387 |
08/15/1984 |
ACA BENZODIAZEPINES SCREEN TEST PK |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K842385 |
08/17/1984 |
ACA CONJUGATED BILIRUBIN ANALYTICAL |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K843116 |
08/17/1984 |
DISPOSABLE SKIN MARKING PEN |
E.M. ADAMS |
|
K840907 |
08/02/1984 |
POST-AID |
E.W. LINK, INC. |
|
K843149 |
08/27/1984 |
KODAK T-MAT C FILM SO-119 |
EASTMAN KODAK COMPANY |
|
K843148 |
08/27/1984 |
KODAK T-MAT H FILM SO-118 |
EASTMAN KODAK COMPANY |
|
K843176 |
08/27/1984 |
KODAK X-OMATIC RADIATION THERAPY CASS |
EASTMAN KODAK COMPANY |
|
K841549 |
08/14/1984 |
HEMOCLIP AUTOMATIC CLIPS MEDIUM |
EDWARD WECK, INC. |
|
K841548 |
08/14/1984 |
HEMOCLIP LIGATING CLIPS M/LARGE |
EDWARD WECK, INC. |
|
K841547 |
08/14/1984 |
HEMOCLIP LIGATING CLIPS MED/SML |
EDWARD WECK, INC. |
|
K843119 |
08/17/1984 |
ETI TENS BELT |
ELECTRO THERAPEUTIC DEVICES, INC. |
|
K842831 |
08/27/1984 |
BAIM CORONARY SINUS FLOW CALCULATOR |
ELECTRO-CATHETER CORP. |
|
K842369 |
08/27/1984 |
ELECATH INFANT ARTERIAL & VENOUS CANNU |
ELECTRO-CATHETER CORP. |
|
K842911 |
08/21/1984 |
PUCK U & UD CUTFILM CHANGERS |
ELEMA-SCHONANDER, INC. |
|
K842903 |
08/21/1984 |
SEP PROGRAMMER FOR PUCK U & UD FILMCHANG |
ELEMA-SCHONANDER, INC. |
|
K843108 |
08/27/1984 |
SYSTEMATE ALBUMIN |
EM DIAGNOSTIC SYSTEMS, INC. |
|
K843152 |
08/29/1984 |
SYSTEMATE CALCIUM 67214 |
EM DIAGNOSTIC SYSTEMS, INC. |
|
K843105 |
08/27/1984 |
SYSTEMATE CREATININE 67223 |
EM DIAGNOSTIC SYSTEMS, INC. |
|
K843151 |
08/27/1984 |
SYSTEMATE GLUCOSE 67215 |
EM DIAGNOSTIC SYSTEMS, INC. |
|
K843150 |
08/27/1984 |
SYSTEMATE GLUCOSE 67216 |
EM DIAGNOSTIC SYSTEMS, INC. |
|
K843107 |
08/27/1984 |
SYSTEMATE TOTAL PROTEIN 67218 |
EM DIAGNOSTIC SYSTEMS, INC. |
|
K843106 |
08/27/1984 |
SYSTEMATE TRIGLYCERIDE 67219 |
EM DIAGNOSTIC SYSTEMS, INC. |
|
K842124 |
08/08/1984 |
EMG MODULE, EMG1, W/OPTIONAL SPEAKER |
ENDOTEK CORP. |
|
K842844 |
08/17/1984 |
DENTI-D RUBBER DAM |
FEMA CORP. |
|
K840152 |
08/30/1984 |
FERRIS VENT-A-DERM |
FERRIS MFG. CORP. |
|
K840055 |
08/22/1984 |
DYNASCOPE SERIES |
FUKUDA DENSHI USA, INC. |
|
K840949 |
08/17/1984 |
CLEAR PLASTIC-HYPOALLERGENIC |
GAINOR MEDICAL |
|
K840948 |
08/14/1984 |
CLEAR POROUS PLASTIC-HYPOALLERGENIC |
GAINOR MEDICAL |
|
K840947 |
08/17/1984 |
CLOTH-HYPOALLERGENIC |
GAINOR MEDICAL |
|
K840946 |
08/17/1984 |
MICROPOROUS HYPOALLERGENIC |
GAINOR MEDICAL |
|
K842503 |
08/10/1984 |
GAMBRO PULSATILE MONITOR PLM 10-200 |
GAMBRO, INC. |
|
K842485 |
08/10/1984 |
OPTICLEAR |
GELMAN SCIENCES, INC. |
|
K842560 |
08/10/1984 |
OPTIPHOR-10 |
GELMAN SCIENCES, INC. |
|
K842463 |
08/02/1984 |
GX CEPH |
GENDEX CORP. |
|
K842348 |
08/17/1984 |
SPX GENERATOR |
GENERAL ELECTRIC CO. |
|
K842683 |
08/02/1984 |
GENETIC SYS LEGIONELLA IMMUNOFLURORES |
GENETIC SYSTEMS CORP. |
|
K842500 |
08/16/1984 |
DATA MGMT. SYSTEM |
GILFORD |
|
K842515 |
08/02/1984 |
SURGICAL HEADLIGHT |
GOOD-LITE CO. |
|
K843074 |
08/17/1984 |
DISPOS. & SPONGE FORCEPS PEAN ARTERY |
GREENE INTERNATIONAL CORP. |
|
K843073 |
08/24/1984 |
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP |
GREENE INTERNATIONAL CORP. |
|
K842649 |
08/10/1984 |
BATH TUB TRANSFER CHAIR |
GUARDIAN PRODUCTS CO., INC. |
|
K842651 |
08/07/1984 |
COMMODE CHAIR 98200 |
GUARDIAN PRODUCTS CO., INC. |
|
K842650 |
08/10/1984 |
WALL GRAB BARS 98130-98136 |
GUARDIAN PRODUCTS CO., INC. |
|
K841275 |
08/17/1984 |
FINE NEEDLE ASPIRATION DEVICE |
GYNECO, INC. |
|
K842634 |
08/10/1984 |
PFLEX RESPIRATORY MUSCLE EXERCISER |
HEALTHSCAN, INC. |
|
K840903 |
08/10/1984 |
HELENA COLOSCREEN SELF-TEST |
HELENA LABORATORIES |
|
K840140 |
08/23/1984 |
DOPPLER IMAGING OPTION |
HEWLETT-PACKARD CO. |
|
K843262 |
08/23/1984 |
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO |
HEWLETT-PACKARD CO. |
|
K842449 |
08/16/1984 |
HICHEM ION 2/4 SERUM RANGE CALIBRATOR |
HI CHEM, INC. |
|
K842450 |
08/16/1984 |
HICHEM ION 2/4 URINE RANGE CALIBRATOR |
HI CHEM, INC. |
|
K842367 |
08/17/1984 |
HOWMEDICA KINEMATIC II TIBIAL WEDGE |
HOWMEDICA CORP. |
|
K842633 |
08/23/1984 |
TANDEM FAST VISUAL HCG ASSAY KIT - |
HYBRITECH, INC. |
|
K842304 |
08/01/1984 |
THE PATHFINDER |
HYDRO-MED PRODUCTS, INC. |
|
K842709 |
08/03/1984 |
IMMUSTAPH LATEX AGGLUTINATION KIT |
IMMUCELL CORP. |
|
K842050 |
08/03/1984 |
IMPACT MODEL 316 |
IMPACT INSTRUMENTATION, INC. |
|
K842580 |
08/24/1984 |
ACCESSORY FOR ADULT VOL. VENTILATOR |
INFRASONICS CORP. |
|
K843036 |
08/15/1984 |
PATIENT BREATHING CIRCUIT |
INFRASONICS CORP. |
|
K842355 |
08/06/1984 |
INFUSAID INFUSE-A-PORT |
INFUSAID CORP. |
|
K842865 |
08/15/1984 |
ESOPHAGEAL STETHOSCOPE |
INMED CORP. |
|
K841040 |
08/17/1984 |
FOX POST NASAL BALLOON CATHETER |
INMED CORP. |
|
K841201 |
08/03/1984 |
POROUS HYDROXYAPATITE BG200 |
INTERPORE INTL. |
|
K842749 |
08/28/1984 |
FIAX TOTAL IGE TEST KIT |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K842869 |
08/07/1984 |
DECARBOXYLASE TEST REAGENT |
IRVINE DIAGNOSTIC SERVICES |
|
K842868 |
08/03/1984 |
HIPPURATE TEST DISKS |
IRVINE DIAGNOSTIC SERVICES |
|
K842871 |
08/07/1984 |
HIPPURATE TEST REAGENT |
IRVINE DIAGNOSTIC SERVICES |
|
K842872 |
08/03/1984 |
INDOLE REAGENT |
IRVINE DIAGNOSTIC SERVICES |
|
K842870 |
08/03/1984 |
VOGES-PROSKAUER REAGENT A |
IRVINE DIAGNOSTIC SERVICES |
|
K842867 |
08/03/1984 |
VOGES-PROSKAUER REAGENT B |
IRVINE DIAGNOSTIC SERVICES |
|
K842879 |
08/10/1984 |
ALPHACOIL |
JAPAN PARA SCIENCE INSTITUTE |
|
K843155 |
08/24/1984 |
SURE & NATURAL DEODORANT MAXI-SHIELD |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K842882 |
08/08/1984 |
ANKLE MOBILIZER |
JOINT MOBILIZER SYSTEMS, INC. |
|
K842881 |
08/08/1984 |
KNEE-HIP MOBILIZER |
JOINT MOBILIZER SYSTEMS, INC. |
|
K841294 |
08/15/1984 |
ACU220 CRYO UNIT |
KELLER INSTRUMENTS, INC. |
|
K842894 |
08/27/1984 |
KEMBLE 405 |
KEMBLE INSTRUMENTS, INC. |
|
K843022 |
08/24/1984 |
KERR COMMAND ULTRAFINE POLISHING PASTE |
KERR CORPORATION (DANBURY) |
|
K842750 |
08/17/1984 |
OSMOTIC PRESSURE AUTO & STAT OM-6010 |
KYOTO DIAGNOSTICS, INC. |
|
K842997 |
08/27/1984 |
LASER RECTOSCOPE SET 784 |
LASER INDUSTRIES LTD. |
|
K840447 |
08/17/1984 |
MICROPOROUS MED. ADHESIVE TAPE |
LECTEC CORP. |
|
K843169 |
08/20/1984 |
CUSHION-FLEX TM |
LIFE DESIGN SYSTEMS, INC. |
|
K833737 |
08/24/1984 |
CPR LOCATOR |
LIFE POINT, INC. |
|
K842876 |
08/29/1984 |
PORTABLE LIFECARE VENTILATOR PLV-102 |
LIFECARE SERVICES, INC. |
|
K841929 |
08/08/1984 |
LIFEMED LIFECOIL CATHETERS |
LIFEMED OF CALIFORNIA |
|
K842235 |
08/27/1984 |
SERVOCARD DEFIBRILLATOR SCP-851 |
LITTON DATAMEDIX |
DAVID O JONES |
K842312 |
08/27/1984 |
SERVOCARD SCP-840 |
LITTON DATAMEDIX |
DAVID O JONES |
K842570 |
08/07/1984 |
LUDLUM 88 DOSE CALIBRATOR |
LUDLUM MEASUREMENTS, INC. |
|
K842345 |
08/17/1984 |
MAXIFILL TRANSFER SET |
LYPHOMED, INC. |
|
K842667 |
08/27/1984 |
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE |
MARQUETTE ELECTRONICS, INC. |
RICHARD E FLEEHARTY |
K842494 |
08/17/1984 |
MATRIS INSTRU. VIDEO IMAGER 1010- |
MATRIX INSTRUMENTS |
|
K842495 |
08/17/1984 |
MATRIX VIDEO IMAGER 1020 COMPACT CAMER |
MATRIX INSTRUMENTS |
|
K842076 |
08/14/1984 |
MIC GASTROSTOMY TUBE |
MEDICAL INNOVATIONS CORP. |
|
K842820 |
08/14/1984 |
ARTHROSCOPY KNIVES |
MEDTECH INDUSTRIES, INC. |
|
K842819 |
08/14/1984 |
HOOK PUNCH FORCEPS FOR ARTHROSCOPY |
MEDTECH INDUSTRIES, INC. |
|
K842780 |
08/03/1984 |
MEDTRONIC 6210 PERMANENT LEAD INTRODUC |
MEDTRONIC VASCULAR |
|
K843089 |
08/29/1984 |
MEDTRONIC 8437/8438 |
MEDTRONIC VASCULAR |
|
K842812 |
08/08/1984 |
MENTOR 150 PLUS TRANSCUTANEOUS ELEC. |
MENTOR CORP. |
|
K842883 |
08/17/1984 |
RADOVAN TISSUE EXPANDER |
MENTOR CORP. |
|
K842014 |
08/17/1984 |
HOSPITAL'S-SPEC |
MEREX CO. |
|
K842955 |
08/09/1984 |
SICKLE-HEME A/S HETEROZYGOUS CONTROL |
MICHCLONE ASSOCIATES, INC. |
|
K842902 |
08/09/1984 |
MICROSTAT GAMMA COUNTER |
MICROMEDIC SYSTEMS |
|
K842592 |
08/17/1984 |
AMES TDA PHENOBARBITAL TEST |
MILES LABORATORIES, INC. |
|
K841041 |
08/24/1984 |
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR |
MILES LABORATORIES, INC. |
|
K842237 |
08/15/1984 |
CLINITEK 200 SEMI-AUTOMATED URINALYSIS |
MILES LABORATORIES, INC. |
|
K842468 |
08/28/1984 |
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG |
MILES LABORATORIES, INC. |
|
K842470 |
08/28/1984 |
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM |
MILES LABORATORIES, INC. |
|
K842762 |
08/17/1984 |
OMNI-TRACT SURGICAL RETRACTOR SYS |
MINNESOTA SCIENTIFIC, INC. |
|
K842130 |
08/08/1984 |
G.I. CLEANSING KIT |
MMI, INC. |
MARTIN MATTLER |
K842335 |
08/01/1984 |
PILLOW W/STAPHCHEK TICKING |
MONTEREY MILLS, INC. |
|
K841261 |
08/10/1984 |
COMPUTER, CENTRAL PROCESSING UNIT |
NEM COMPUTER CORP. |
|
K842956 |
08/03/1984 |
NICOLET VIKING |
NICOLET BIOMEDICAL INSTRUMENTS |
|
K841501 |
08/28/1984 |
LIFESCOPE 6 OEC-6102 |
NIHON KOHDEN AMERICA, INC. |
|
K841502 |
08/28/1984 |
LIFESCOPE 6 OEC-6105 |
NIHON KOHDEN AMERICA, INC. |
|
K841500 |
08/28/1984 |
LIFESCOPE 6 OEC-6201 |
NIHON KOHDEN AMERICA, INC. |
|
K841499 |
08/28/1984 |
LIFESCOPE II |
NIHON KOHDEN AMERICA, INC. |
|
K842486 |
08/24/1984 |
ELECTRONIC DIGITAL BP METER HC 3001 |
NORTH AMERICAN PHILIPS CORP. |
|
K842992 |
08/17/1984 |
GRASSHOPPER - RETRACTOR |
NORTON TEXAS MEDICAL PRODUCTS |
|
K842194 |
08/27/1984 |
PRESSURE MONITOR |
NORTON TEXAS MEDICAL PRODUCTS |
RICK FOSTER |
K842841 |
08/14/1984 |
VIVONEX TUNG STEN TIP TUBE |
NORWICH EATON PHARMACEUTICALS, INC. |
|
K840009 |
08/22/1984 |
NOVA 12 CARDIAC OUTPUT COMPUTER |
NOVA MEDICAL SPECIALTIES |
|
K841639 |
08/12/1984 |
NOVA BALLOON THERMODILUTION CATH. |
NOVA MEDICAL SPECIALTIES |
|
K841640 |
08/12/1984 |
NOVA BALLOON THERMODILUTION INFUSION |
NOVA MEDICAL SPECIALTIES |
|
K840748 |
08/03/1984 |
LITHIUM PACEMAKER 811-811L & 811XL |
OMIKRON SCIENTIFIC, LTD. |
|
K841369 |
08/23/1984 |
BETA SCAN DRYSTIX |
ORANGE MEDICAL INSTRUMENTS, INC. |
|
K842215 |
08/02/1984 |
ASCORBIC ACID |
ORGANON TEKNIKA CORP. |
|
K842302 |
08/27/1984 |
FLUID WARMER |
ORGANON TEKNIKA CORP. |
|
K842314 |
08/24/1984 |
DUOCLON COLOR-CEPT |
ORGANON, INC. |
|
K842790 |
08/08/1984 |
ORTHO ACTIVE KNEE BRACE |
ORTHO ACTIVE APPLIANCES LTD. |
|
K842791 |
08/08/1984 |
ORTHO ACTIVE WRIST BRACE |
ORTHO ACTIVE APPLIANCES LTD. |
|
K841527 |
08/12/1984 |
ORTHO RESPIRATORY SYNCYTIAL VIRUS- |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K842163 |
08/09/1984 |
RIDGEMATRIX 20/40 MESH, PERIOMATRIX |
ORTHOMATRIX, INC. |
|
K842074 |
08/23/1984 |
EARETTE HEARING AID OTICON E30V |
OTICON CORP. |
|
K842073 |
08/23/1984 |
EARETTE HEARING AID OTICON E31V |
OTICON CORP. |
|
K843065 |
08/20/1984 |
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG |
OTISVILLE BIOTECH, INC. |
|
K843066 |
08/20/1984 |
BIOTIS CIN AGAR PLATES |
OTISVILLE BIOTECH, INC. |
|
K841885 |
08/03/1984 |
FASTPASS IMPLANTABLE ENDOCARDIAL PAC |
PACESETTER SYSTEMS |
|
K841739 |
08/03/1984 |
MODEL 866 PERMATHANE BIPOLAR, COAXIAL |
PACESETTER SYSTEMS |
|
K834380 |
08/03/1984 |
PALL EC PLUS FILTER |
PALL BIOMEDICAL PRODUCTS CO. |
|
K834382 |
08/03/1984 |
PALL EC PLUS FILTER W/FILTER SLEEVE |
PALL BIOMEDICAL PRODUCTS CO. |
|
K842141 |
08/03/1984 |
SOLUTION CLARIFICATION UNIT |
PALL BIOMEDICAL PRODUCTS CO. |
|
K841968 |
08/06/1984 |
DESERET DISPOSABLE PRESSURE TRANSDUCER |
PARKE-DAVIS CO. |
|
K841312 |
08/20/1984 |
ASSURE-BREATHABLE PANTY LINERS/SCENT |
PERSONAL PRODUCTS CO. |
|
K841311 |
08/20/1984 |
ASSURE-BREATHABLE PANTY LINERS/UNSCENT |
PERSONAL PRODUCTS CO. |
|
K842055 |
08/24/1984 |
PICKER ARTIS ULTRASOUND IMAGING SYS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K842941 |
08/03/1984 |
MULTIPLE PLANETAMED;PLANETA HYDROMASS |
PLANETA HAUSGERAETE KG |
|
K841629 |
08/27/1984 |
DRILL BIT |
PLASTAFIL, INC. |
|
K841625 |
08/27/1984 |
HOOK |
PLASTAFIL, INC. |
|
K841627 |
08/27/1984 |
MALLET |
PLASTAFIL, INC. |
|
K841624 |
08/27/1984 |
PROBE |
PLASTAFIL, INC. |
|
K841626 |
08/27/1984 |
PUNCH |
PLASTAFIL, INC. |
|
K841617 |
08/27/1984 |
STROVER HOOK |
PLASTAFIL, INC. |
|
K841618 |
08/27/1984 |
THREADING TUBE |
PLASTAFIL, INC. |
|
K843009 |
08/24/1984 |
BP-1000 |
POLLENEX ASSOCIATED MILLS, INC. |
|
K842406 |
08/09/1984 |
WESCOTT TYPE BIOPSY NEEDLE |
POPPER & SONS, INC. |
|
K843070 |
08/24/1984 |
ESOPHAGEAL STETHOSCOPES |
PRIMROSE MEDICAL, INC. |
|
K843071 |
08/24/1984 |
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR |
PRIMROSE MEDICAL, INC. |
|
K842405 |
08/15/1984 |
DR. GOULD HAND PACK SUSTOM STERIL |
PRO-LAB, INC. |
|
K842958 |
08/17/1984 |
BOUNDARY SINGLE-USE OR GOWN |
PROCTER & GAMBLE MFG. CO. |
|
K842764 |
08/10/1984 |
SCENTED MENSTRUAL PAD |
PROCTER & GAMBLE MFG. CO. |
|
K842763 |
08/10/1984 |
UNSCENTED MENSTRUAL PAD |
PROCTER & GAMBLE MFG. CO. |
|
K843243 |
08/22/1984 |
COMPANION 492 OXYGEN CONCENTRATOR |
PURITAN BENNETT CORP. |
|
K841611 |
08/02/1984 |
QUINTON 901 & 900 HOLTER SCANNER |
QUINTON, INC. |
|
K842746 |
08/17/1984 |
HYCEL ROTOR-MIXER AND/OR MULTI |
R & D SYSTEMS, INC. |
|
K841933 |
08/10/1984 |
RADIOEAR M420H |
RADIOEAR CORP. |
|
K842567 |
08/15/1984 |
PORTABLE ACUIOMETER |
RANDWAL INSTRUMENT CO., INC. |
|
K841847 |
08/17/1984 |
LITHIUM REAGENT |
REAGENT LABORATORY, INC. |
|
K843051 |
08/03/1984 |
WRIGHTS STAIN SOLUTION |
REAGENT LABORATORY, INC. |
|
K841898 |
08/14/1984 |
FIRST RESPONSE EMERG. MEDICSL - BURNS |
REED PRODUCTS, INC. |
|
K840841 |
08/07/1984 |
RENEAU UNIT |
RENEAU, INC. |
|
K842693 |
08/10/1984 |
RESPIRONICS VENTEASY |
RESPIRONICS, INC. |
|
K842875 |
08/24/1984 |
RIONET HEARING AID HB-35 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K841935 |
08/14/1984 |
RIONET HEARING AID HI-03 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K842519 |
08/17/1984 |
BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 |
RNA MEDICAL CORP. |
|
K842804 |
08/21/1984 |
DIADYN 4 |
ROBERT BOSCH CORP. |
|
K842805 |
08/01/1984 |
IMPULS 3, IT SELECTOR |
ROBERT BOSCH CORP. |
|
K842803 |
08/21/1984 |
INTERFERENZ 4 |
ROBERT BOSCH CORP. |
|
K842801 |
08/01/1984 |
ULTRAMED 11S601 |
ROBERT BOSCH CORP. |
|
K842802 |
08/01/1984 |
VACOMED 4 |
ROBERT BOSCH CORP. |
|
K842516 |
08/17/1984 |
SANDARE ACID PHOSPHATASE PROCEDURE |
SANDARE CHEMICAL CO., INC. |
|
K842483 |
08/31/1984 |
SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC |
SANTA BARBARA MEDCO, INC. |
|
K841521 |
08/03/1984 |
SCANLAN ENDARSECTOR |
SCANLAN INTL., INC. |
|
K842491 |
08/10/1984 |
SDC SILICONE FORCEP SHODS PRODUCT |
SCIENCE DEVELOPMENT CORP. |
|
K842403 |
08/17/1984 |
LUSTER, DENTAL POLISHING PASTE |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
K843146 |
08/17/1984 |
MICRO-TEMP PUMPS & MICRO-TEMP PADS |
SEABROOK MEDICAL SYSTEMS, INC. |
|
K841769 |
08/24/1984 |
INTERMITTENT URETHRAL CATHETER TRAY |
SEAMLESS HOSPITAL PRODUCTS CO. |
|
K842181 |
08/22/1984 |
BETA-HCG HEMAGGLUTINATION TEST |
SERO-IMMUNO DIAGNOSTICS, INC. |
|
K842846 |
08/17/1984 |
SEWON DENTAL FLOSS FOLDER |
SEWON INDUSTRY |
|
K842656 |
08/12/1984 |
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL |
SHABAN MFG. CO. |
|
K842889 |
08/27/1984 |
ARGYLE CUSTOM TUBING PACK |
SHERWOOD MEDICAL CO. |
|
K842421 |
08/17/1984 |
ARGYLE ENTERITE ENTERAL FEEDING PUMP |
SHERWOOD MEDICAL CO. |
|
K840198 |
08/03/1984 |
ARTERIAL EMBOLECTOMY CATHETER |
SHILEY, INC. |
|
K841797 |
08/10/1984 |
MULTIPRO CATHETER |
SHILEY, INC. |
|
K842711 |
08/10/1984 |
SHILEY CARDIOTOMY RESERVOIR W/FILTER |
SHILEY, INC. |
|
K842337 |
08/17/1984 |
SHILEY VENOUS RESERVOIR |
SHILEY, INC. |
|
K841905 |
08/09/1984 |
DOT-A, DOT-AR PXP-E, PXP-ER |
SIEMENS GAMMASONICS, INC. |
|
K842895 |
08/27/1984 |
WBA - I.R.I.S. |
SIEMENS GAMMASONICS, INC. |
|
K840893 |
08/02/1984 |
CONFERETTE C2 |
SIEMENS HEARING INSTRUMENTS, INC. |
|
K843086 |
08/28/1984 |
DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX |
SIGMA CHEMICAL CO. |
|
K843045 |
08/12/1984 |
LACTALBUMIN HYDROLYSATE MED. CATALOG |
SIGMA CHEMICAL CO. |
|
K843043 |
08/14/1984 |
MED. 199 CATALOG M3769 W/EARLE'S SALT |
SIGMA CHEMICAL CO. |
|
K842775 |
08/17/1984 |
MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB |
SIGMA CHEMICAL CO. |
|
K843044 |
08/14/1984 |
MINIM. ESSENTIAL MED. EAGLE M4144 W/ |
SIGMA CHEMICAL CO. |
|
K842776 |
08/20/1984 |
MINIMUM ESSENTIAL MED W/L-GLUTAMINE |
SIGMA CHEMICAL CO. |
|
K843085 |
08/28/1984 |
RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA |
SIGMA CHEMICAL CO. |
|
K842411 |
08/12/1984 |
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS |
SIGMA CHEMICAL CO. |
|
K842564 |
08/12/1984 |
SIGMA 59-UV FOR ALANINE AMINOTRANSFER |
SIGMA CHEMICAL CO. |
|
K842765 |
08/17/1984 |
SILIMED BREAST FORM |
SIL-MED CORP. |
|
K842575 |
08/10/1984 |
ULTRA-VIOLET A SOURCE LIGHT EMITTING |
SOLA-TAN INTL. |
|
K842384 |
08/08/1984 |
ULTRA-VIOLET EMITTING SUNLAMP PRODUCT |
SOLA-TAN INTL. |
|
K842106 |
08/10/1984 |
LEE BONE MARROW NEEDLES |
SOUTHLAND INSTRUMENTS, INC. |
PETER F LEE |
K842978 |
08/24/1984 |
540 CAPNOGRAPH |
SPACELABS, INC. |
|
K842334 |
08/30/1984 |
LIFE MONITOR I |
ST. CROIX MEDICAL SYSTEMS, INC. |
|
K841980 |
08/15/1984 |
SIDE CUTTING SERRATED BLADE |
STAINLESS MFG., INC. |
|
K841850 |
08/24/1984 |
CUSTOM STERILE PROCEDURE TRAYS-MULTI |
STERILCO, INC. |
|
K842521 |
08/12/1984 |
AST/GOT REAGENT SET UV RATE |
STERLING BIOCHEMICAL, INC. |
|
K842787 |
08/15/1984 |
SUNBED |
SUN HEALTH SYSTEMS |
|
K842275 |
08/14/1984 |
ULTRASONIC COOL SPRAY HUMIDIFIER |
SUNBEAM CORP. |
|
K842444 |
08/17/1984 |
FSH RIA |
SYNCOR INTL. CORP. |
|
K843160 |
08/29/1984 |
EMIT 700 COCAINE METABOLITE ASSAY |
SYVA CO. |
|
K843161 |
08/29/1984 |
EMIT 700 CONTROL SET A |
SYVA CO. |
|
K842673 |
08/12/1984 |
EMIT LOW & MEDIUM CALIBRATORS A |
SYVA CO. |
|
K842623 |
08/02/1984 |
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT |
SYVA CO. |
|
K842951 |
08/23/1984 |
MAXITHINS BODY-SHAPED PANTY SHIELDS |
TAMBRANDS, INC. |
|
K842952 |
08/22/1984 |
REGULAR MAXITHINS BODY-SHAPED MAXI |
TAMBRANDS, INC. |
|
K842950 |
08/23/1984 |
SUPER MAXITHINS BODY-SHAPED MAXI PADS |
TAMBRANDS, INC. |
|
K843061 |
08/24/1984 |
TAMBRANDS INC. ILL.P. 2 |
TAMBRANDS, INC. |
|
K842657 |
08/17/1984 |
ACCESS. TO INTERAVACULAR ADMIN. SET |
TANNER CORP. |
|
K834442 |
08/08/1984 |
LED STIMULATOR LS-05 |
TECA, INC. |
|
K842230 |
08/17/1984 |
AIMED DISPOS. INJECTION NEEDLE |
TECH-CONS LTD., INTL. |
|
K842255 |
08/17/1984 |
AIMED SCALP VEIN SET VARIOUS |
TECH-CONS LTD., INTL. |
|
K841817 |
08/17/1984 |
TECHNICARE 248 SL & 260SL |
TECHNICARE CORP. |
|
K842809 |
08/17/1984 |
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN |
TECHNICON INSTRUMENTS CORP. |
|
K842898 |
08/17/1984 |
CURITY I.V. START KIT |
THE KENDAL CO. |
|
K842496 |
08/10/1984 |
ICP/6500 INDUCTIVELY-COUPLED PLASMA- |
THE PERKIN-ELMER CORP. |
|
K842752 |
08/22/1984 |
ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT |
THE PERKIN-ELMER CORP. |
|
K842573 |
08/10/1984 |
T.P.G. CAST TAPE |
THE POLY GROUP, INC. |
|
K831809 |
08/27/1984 |
FOGARTY OCCLUDER PAD |
THOMAS J. FOGARTY, M.D. |
|
K842985 |
08/07/1984 |
T- EXTENSION SET T-04-C |
TICO MEDICAL INSTRUMENTS, INC. |
|
K833170 |
08/12/1984 |
FLUSH DEVICE |
TRANSAMERICA DELAVAL, INC. |
|
K841923 |
08/10/1984 |
DCX-100 CHEST UNIT-GL-5000M |
TRANSWORLD X-RAY CORP. |
|
K840845 |
08/16/1984 |
HOLLOW FIBER DIALYZERS |
TRAVENOL LABORATORIES, S.A. |
JULIA MEYER |
K841357 |
08/24/1984 |
MICRO FLUID APPLICATOR |
TREACE MEDICAL, INC. |
|
K840391 |
08/27/1984 |
ANGIOGRAPHIC PROCEDURE TRAY |
TRIAD MEDICAL DIVISION |
BUD BOYNTON |
K842609 |
08/09/1984 |
R.L. MEDICAL TWIN LIGHT SOURCE |
TRIDAK DIVISION OF INDICON, INC. |
|
K840961 |
08/10/1984 |
ESCHWEILER COMBI-ANALYSER MTA-500 |
U.S. SCIENCE, INC. |
|
K842572 |
08/15/1984 |
GAUZE & LAB SPONGES STERILE & NON |
ULTI-MED INTL., INC. |
|
K842315 |
08/02/1984 |
ULTRA LYTE ANALYZER I 100 |
ULTRA QUEST DIAGNOSTICS, INC. |
|
K842259 |
08/01/1984 |
PCI W/CATH-SEAL SIDE FLOW FITTING |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
|
K841941 |
08/08/1984 |
VAN-TEC OCCLUSION BALLOON CATHETER |
VAN-TEC, INC. |
|
K841940 |
08/03/1984 |
VAN-TEC URETERAL DILATION BALLOON CATH |
VAN-TEC, INC. |
|
K842864 |
08/08/1984 |
VACCESS FEMORAL CANNULA |
VAS-CATH OF CANADA LTD. |
|
K842264 |
08/14/1984 |
VENTREZYME PHENOBARBITAL KIT IMMUNO |
VENTREX LABORATORIES, INC. |
|
K842088 |
08/17/1984 |
FLU MET 2 |
VENUSA LTD. |
|
K842912 |
08/15/1984 |
THE SUTURER |
VLM SURGICAL, INC. |
|
K842988 |
08/07/1984 |
VMT GENTLE-HALER |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
|
K842452 |
08/15/1984 |
WAKO LDH CII TEST |
WAKO CHEMICALS, USA, INC. |
|
K841795 |
08/30/1984 |
UV 8001K, PUVA 800, PUVA 180/200 1000 |
WALDMANN LIGHTING CO. |
|
K842254 |
08/20/1984 |
MEDICAL EMERG. STABILIZER OBJECT/BODY |
WALTER ANSTED CO. |
|
K833369 |
08/02/1984 |
EARLY DETECTOR |
WARNER-LAMBERT CO. |
|
K842293 |
08/02/1984 |
PARTIALLY THREADED BONE FIX. PIN |
WARSAW ORTHOPEDIC, INC. |
|
K834408 |
08/23/1984 |
TX-2 THERMAL DILUTION CARDIAC OUTPUT |
WATERS INSTRUMENTS, INC. |
|
K842975 |
08/17/1984 |
BROWNIE BOOTH BB1 |
WEINGART, INC. |
|
K842379 |
08/10/1984 |
ELECTRO-SAGE MODEL 203 |
WEINGART, INC. |
|
K842827 |
08/16/1984 |
STREPTEX DIRECT A ZL14 |
WELLCOME DIAGNOSTICS |
|
K842828 |
08/15/1984 |
STREPTEX ZL01 |
WELLCOME DIAGNOSTICS |
|
K841762 |
08/02/1984 |
WOODLYN APPLANATION TONOMETER |
WOODLYN, INC. |
|
K841764 |
08/07/1984 |
WOODLYN CLASSIC JAVAL OPHTHALMOMETER |
WOODLYN, INC. |
|
K841767 |
08/07/1984 |
WOODLYN CLASSIC KERATOMETER |
WOODLYN, INC. |
|
K841761 |
08/07/1984 |
WOODLYN CLASSIC SLIT LAMP HSSL-CL |
WOODLYN, INC. |
|
K841763 |
08/02/1984 |
WOODLYN SLIT LAMP HSSL-EC |
WOODLYN, INC. |
|
K841765 |
08/07/1984 |
WOODLYN STANDARD SLIT LAMP HSSL-ST |
WOODLYN, INC. |
|
K842963 |
08/17/1984 |
RHYS-DAVIES EXSANGUINATOR |
WOODVILLE POLYMER ENGINEERING, LTD. |
|
K842419 |
08/07/1984 |
IVAC 280 VOLUMETRIC INFUSION CONTROLLER |
Y |
|
K842589 |
08/14/1984 |
IVAC KEOFEED HYDROPHILIC FEEDING TUBE |
Y |
|
K842906 |
08/24/1984 |
BIAS TOTAL HIP |
ZIMMER, INC. |
|
K841517 |
08/30/1984 |
CLOUTIER II TOTAL KNEE W/BEADED SURF |
ZIMMER, INC. |
|