| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K842382 |
06/18/1984 |
3M RAPIDSTAT LIGATING CLIP SYS |
3M COMPANY |
|
| K842523 |
06/27/1984 |
BIRD HEATED HUMIDIFIER 3201 |
3M COMPANY |
|
| K842446 |
06/21/1984 |
DILU-MATIC 140 |
ABBOTT DIAGNOSTICS |
|
| K842522 |
06/27/1984 |
PDA SYSTEM |
ABBOTT LABORATORIES |
|
| K842280 |
06/08/1984 |
TDX DIGITOXIN |
ABBOTT LABORATORIES |
|
| K842320 |
06/12/1984 |
TDX REA CHOLESTEROL |
ABBOTT LABORATORIES |
|
| K842505 |
06/26/1984 |
TDX REA IRON DIAGNOSTIC KIT |
ABBOTT LABORATORIES |
|
| K842231 |
06/05/1984 |
ACKRAD HYSTEROSALPINGOGRAPHY SET |
ACKRAD LABORATORIES |
|
| K842186 |
06/01/1984 |
ACU-DERM TRANSPARENT WOUND DRESSING |
ACME UNITED CORP. |
|
| K842195 |
06/04/1984 |
ADVANCED CARDIOVASCULAR-CORONARY GUID |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
|
| K842265 |
06/07/1984 |
ORTHO BRAND HOME PREGNANCY TEST |
ADVANCED CARE PRODUCTS |
|
| K842376 |
06/18/1984 |
ULTRAMARK 4 ULTRASOUND SYS |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
|
| K842462 |
06/22/1984 |
HOLTER SCREENING MONITOR HS-221 |
ADVANTAGE MEDICAL SYSTEMS, INC. |
|
| K842321 |
06/12/1984 |
AIR SHIELDS AS461 MONITORING SYS |
AIR-SHIELDS, INC. |
|
| K842415 |
06/20/1984 |
ALL-HANDS TRACHEOSTOMY CARE SET 0101 |
ALL-HANDS MEDICAL SUPPLY, INC. |
|
| K842430 |
06/20/1984 |
ALLIED ASSOC. THERAP. EXERCISE EQUIP |
ALLIED ASSOCIATES, INC. |
|
| K842431 |
06/20/1984 |
ALLIED ASSOC. THERAP. EXERCISE EQUIP- |
ALLIED ASSOCIATES, INC. |
|
| K842429 |
06/20/1984 |
ALLIED ASSOC. THERAPEUTIC EXER EQUIP- |
ALLIED ASSOCIATES, INC. |
|
| K842428 |
06/20/1984 |
ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP |
ALLIED ASSOCIATES, INC. |
|
| K842433 |
06/20/1984 |
ALLIED ASSOC. THERAPEUTIC EXERCISE |
ALLIED ASSOCIATES, INC. |
|
| K842427 |
06/20/1984 |
ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP |
ALLIED ASSOCIATES, INC. |
|
| K842426 |
06/20/1984 |
ALLIED ASSOC. THERAPEUTIC EXERICSE |
ALLIED ASSOCIATES, INC. |
|
| K842425 |
06/20/1984 |
ALLIED ASSOCIATES THERAPEUTIC EXERCISE |
ALLIED ASSOCIATES, INC. |
|
| K842432 |
06/20/1984 |
ALLIED ASSOCIATES THERAPEUTIC EXERSIE |
ALLIED ASSOCIATES, INC. |
|
| K842373 |
06/15/1984 |
VENOUS RESERVOIR-BMR-1500-HARD SHELL |
AMERICAN BENTLEY |
DONALD A RAIBLE |
| K842455 |
06/22/1984 |
AMER. BIO-SCIENCE LAB CORTISOL REAGENT |
AMERICAN BIO-SCIENCE LABORATORIES |
|
| K842196 |
06/04/1984 |
STRATUS PRIMIDONE FLOROMETRIC ENZY |
AMERICAN DADE |
|
| K842537 |
06/28/1984 |
VON WILLEBRAND FACTOR ANTIGEN SCREEN |
AMERICAN DADE |
|
| K842410 |
06/19/1984 |
AMER. EDWARDS LAB FLEXISCOPE |
AMERICAN EDWARDS LABORATORIES |
RONALD J EHMSEN |
| K842323 |
06/13/1984 |
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR |
AMERICAN EDWARDS LABORATORIES |
|
| K842481 |
06/25/1984 |
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE |
AMERICAN EDWARDS LABORATORIES |
RONALD J EHMSEN |
| K842206 |
06/04/1984 |
DIAFLEX NEPHROSTOMY BALLOON DILATOR |
AMERICAN EDWARDS LABORATORIES |
|
| K842504 |
06/26/1984 |
AMER. MEDICAL OPTICS DIGITAL KERATO- |
AMERICAN MEDICAL OPTICS |
|
| K842197 |
06/04/1984 |
AMERICAN MEDICAL OPTICS I/A KIT- IRRIG |
AMERICAN MEDICAL OPTICS |
|
| K842492 |
06/26/1984 |
AMER. MEDICAL PLASTICS CO 20100 |
AMERICAN MEDICAL PLASTICS CO. |
|
| K842466 |
06/25/1984 |
TITANIUM MITTELMEIER TYPE ACETABULAR |
AMERICAN ORTOMED CORP. |
MICHAEL M STEK |
| K842465 |
06/25/1984 |
UNILOC |
AMERICAN ORTOMED CORP. |
MICHAEL M STEK |
| K842198 |
06/04/1984 |
AMER. PHARMASEAL NO TOUCH SATIN CATHET |
AMERICAN PHARMASEAL DIV. AHSC |
|
| K842380 |
06/18/1984 |
PRESSURE RELIEF SEAT CUSHION |
AMERICAN PHARMASEAL DIV. AHSC |
|
| K842482 |
06/25/1984 |
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT |
AMERSHAM CORP. |
|
| K842532 |
06/28/1984 |
AMIZYME-ANA TEST KIT |
AMICO LAB, INC. |
|
| K842533 |
06/28/1984 |
AMIZYME-ANDNA TEST KIT |
AMICO LAB, INC. |
|
| K842525 |
06/28/1984 |
AMIZYME-C TRACHOMATIS TEST KIT |
AMICO LAB, INC. |
|
| K842529 |
06/28/1984 |
AMIZYME-CMV KIT |
AMICO LAB, INC. |
|
| K842530 |
06/28/1984 |
AMIZYME-EBV TEST KIT |
AMICO LAB, INC. |
|
| K842531 |
06/28/1984 |
AMIZYME-HSV TYPES 1 & 2 TEST KITS |
AMICO LAB, INC. |
|
| K842526 |
06/28/1984 |
AMIZYME-LEISHMANIA SPP. TEST KIT |
AMICO LAB, INC. |
|
| K842527 |
06/28/1984 |
AMIZYME-SCHISTOSOMA SPP. TEST KIT |
AMICO LAB, INC. |
|
| K842528 |
06/28/1984 |
AMIZYME-TOXOPLASMA GONDII KIT |
AMICO LAB, INC. |
|
| K842453 |
06/22/1984 |
DISPOSABLE PREPING PAD |
ANAGO, INC. |
|
| K842438 |
06/21/1984 |
DISPOSABLE SURGERY HOOD |
ANAGO, INC. |
|
| K842440 |
06/21/1984 |
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH |
ANCO MEDICAL REAGENTS & ASSOC. |
|
| K842183 |
06/01/1984 |
ADP ANA IFA TEST |
APPLE DIAGNOSTIC PRODUCTS |
|
| K842512 |
06/27/1984 |
EXACTA-FILM |
ARDENT INTL., INC. |
|
| K842209 |
06/04/1984 |
ARM-A-FLOW INTRAVENOUS FLOW REGULATOR |
ARMOUR PHARMACEUTICAL CO. |
DAVID MARCUS |
| K842451 |
06/22/1984 |
RIM STREP KIT |
AUSTIN BIOLOGICAL LABORATORIES |
|
| K842389 |
06/18/1984 |
AVATRON DISPOSABLE I.P.P.B. CIRUCIT |
AVATRON, INC. |
|
| K842441 |
06/21/1984 |
AXIOM STABLE II CHOLESTEROL TEST |
AXIOM, INC. |
|
| K842443 |
06/21/1984 |
AXIOM STABLE II TRIGLYCERIDES TEST |
AXIOM, INC. |
|
| K842442 |
06/21/1984 |
AXIOM STABLE II URIC ACID TEST |
AXIOM, INC. |
|
| K842330 |
06/13/1984 |
AMER. HISTO-ID SYS PRIMARY IGA 2720-21 |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
| K842329 |
06/13/1984 |
AMER. HISTO-ID SYS PRIMARY IGG S7920-11 |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
| K842327 |
06/13/1984 |
AMER. HISTO-ID SYS PRIMARY IGM S7920-31 |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
| K842326 |
06/13/1984 |
AMER. HISTO-ID SYS PRIMARY KIT |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
| K842328 |
06/13/1984 |
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
| K842218 |
06/04/1984 |
ANTI-LEU-4 FITC LYSIN C BUFFER |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
RUSSELL J ARNSBERGE |
| K842253 |
06/07/1984 |
AUGMENTIN 30 MCG SENSI DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K842279 |
06/08/1984 |
BECTEC NR-660 BACTERIAL DETECT SYS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K842252 |
06/07/1984 |
CEFONICID 30 MCG SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K842365 |
06/15/1984 |
CORTI-COTE CORTISOL SOLID PHASE RADIO |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K842363 |
06/15/1984 |
PENLON ANESTHESIA VENTILATOR SERIES 300 |
BEAR MEDICAL SYSTEMS, INC. |
|
| K842362 |
06/15/1984 |
PENLON TRANSPORT VENTILATOR SERIES 350 |
BEAR MEDICAL SYSTEMS, INC. |
|
| K842340 |
06/14/1984 |
VH820 HUMIDIFIER |
BEAR MEDICAL SYSTEMS, INC. |
|
| K842420 |
06/20/1984 |
NORTA SILICONIZED LATEX BALLOON CATH. |
BEIERSDORF, INC. |
JOHN R TREMBLEY |
| K842434 |
06/20/1984 |
BEHING THE EAR HEARING AID T-98 |
BERNAFON, INC. |
|
| K842303 |
06/11/1984 |
MICROSPAN -PH MONITOR |
BIOCHEM INTERNATIONAL, INC. |
DER RUHR |
| K842256 |
06/07/1984 |
AS LATEX PLUS |
BIOKIT USA, INC. |
|
| K842490 |
06/26/1984 |
SKIN SCRUB TRAY STERILE SKIN SCRUB KIT |
BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES |
|
| K842435 |
06/20/1984 |
MODEL T 101 CLINICAL TRANSMITTER |
BIOMETRIC PRODUCTS, INC. |
LOUIS KATCHIS |
| K842401 |
06/19/1984 |
CHEMISTRY CONSOLE |
BIOVATION, INC. |
|
| K842393 |
06/18/1984 |
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE |
BOEHRINGER MANNHEIM CORP. |
|
| K842287 |
06/15/1984 |
MONTGOMERY LARYNGEAL STENT |
BOSTON MEDICAL PRODUCTS, INC. |
|
| K842360 |
06/07/1984 |
DORR HIP PROSTHESIS FEMORAL COMPONENT |
CARBOMEDICS, INC. |
|
| K842394 |
06/19/1984 |
ASTRA 2, ASTRA 3, 4 & 6 |
CARDIAC PACEMAKERS, INC. |
ANN MORRISSEY |
| K842364 |
06/18/1984 |
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR |
CARDIAC PACEMAKERS, INC. |
|
| K842536 |
06/28/1984 |
CDX80 |
CDX CORP. |
|
| K842203 |
06/04/1984 |
LITTMAN TYPE SH-6010, NURSE TYPE |
CHER MEL CORP. |
|
| K842459 |
06/22/1984 |
SITE GILLS STYLE I/A HANDPIECE |
CHIRON VISION CORP. |
|
| K842458 |
06/22/1984 |
SITE SIMCOE STYLE I/A HANDPIECE |
CHIRON VISION CORP. |
|
| K842502 |
06/26/1984 |
WRINKLE CHAPEAU BLACKY |
CIRCLE RUBBER CORP. |
|
| K842349 |
06/15/1984 |
AMBULATORY PH RECORDING DEVICE |
CLINICAL DATA INSTRUMENTS, INC. |
|
| K842396 |
06/19/1984 |
ACCUSEAL LEG BAGS & EXTENSION TUBES |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
| K842398 |
06/19/1984 |
SUR-FIT IRRIGATION ADAPTER FACEPLATE |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
| K842395 |
06/19/1984 |
SUR-FIT NIGHT DRAINAGE CONTAINER SET |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
| K842397 |
06/19/1984 |
URIHESIVE SYS MALE EXTERNAL CATHETER |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
| K842484 |
06/25/1984 |
LEAP LE TEST KIT |
COOPER BIOMEDICAL, INC. |
|
| K842412 |
06/19/1984 |
MODEL 4000 MD-YAG LASER FOR MALIGNANT |
COOPER LASERSONICS, INC. |
|
| K842257 |
06/07/1984 |
CORPAK URINARY DRAINAGE BAG |
CORPAK CO. |
|
| K842346 |
06/14/1984 |
COULTER AUTOMATIC SAMPLE HANDLER |
COULTER ELECTRONICS, INC. |
|
| K842476 |
06/25/1984 |
CREDENT RADIOPAQUE CROWN & BRIDE |
CREDENT CO. |
HENRY KORVIN |
| K842477 |
06/25/1984 |
CREDENT RADIOPAQUE DENTURE RESIN |
CREDENT CO. |
HENRY KORVIN |
| K842316 |
06/12/1984 |
CRITIKON TRIPLE-LUMEN CENTRAL VENOUS |
CRITIKON COMPANY,LLC |
|
| K842324 |
06/13/1984 |
PERFOURM |
CUTTER LABORATORIES, INC. |
STEVEN OJALA |
| K842538 |
06/28/1984 |
ACCUTORR CSM SYSTEM |
DATASCOPE CORP. |
|
| K842204 |
06/04/1984 |
DMI ASPIRATOR 500 |
DEAN MEDICAL INSTRUMENTS, INC. |
|
| K842377 |
06/18/1984 |
MS NONPRECIOUS CROWN & BRIDGE ALLOY |
DENTAL VENTURES OF AMERICA, INC. |
|
| K842273 |
06/08/1984 |
CROWN INDEX TRAY |
DI-EQUI DENTAL PRODUCTS |
|
| K842274 |
06/08/1984 |
F-G-P TRAY |
DI-EQUI DENTAL PRODUCTS |
|
| K842241 |
06/05/1984 |
ALANINE AMINOTRANSFERASE ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842243 |
06/05/1984 |
ALKALINE PHOSPHATASE ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842245 |
06/05/1984 |
ASPARTATE AMINOTRANSFERASE ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842509 |
06/26/1984 |
CALCIUM ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842508 |
06/26/1984 |
CREATINE KINASE ASSAY KIT NAC |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842510 |
06/26/1984 |
GLUCOSE ASSAY KIT-HEXOKINASE |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842506 |
06/26/1984 |
GLUCOSE-TRINDER-ADDAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842507 |
06/26/1984 |
LACTATE DEHYDROGENASE ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842244 |
06/05/1984 |
LACTATE DENYDRO GENASE ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842242 |
06/05/1984 |
UREA ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842246 |
06/05/1984 |
URIC ACID ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
| K842383 |
06/18/1984 |
PATHO DX LATEX AGGLUTINATION STREP A |
DIAGNOSTIC PRODUCTS CORP. |
|
| K842249 |
06/06/1984 |
ACTH NORMAL RANGE |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
|
| K842539 |
06/28/1984 |
DIAGNOSTIC ULTRASOUND 105 & 110 |
DIAGNOSTIC ULTRASOUND CORP. |
GERALD MCMORROW |
| K842294 |
06/11/1984 |
DIALYSATE ADDITIVES |
DIALYSIS PRODUCTS, INC. |
|
| K842286 |
06/13/1984 |
DIA T1, T2 & T3 |
DIATECH, INC. |
|
| K842292 |
06/11/1984 |
CEFONICID 30 MCG SENSITIVITY DISCS |
DIFCO LABORATORIES, INC. |
|
| K842291 |
06/11/1984 |
SPOT TEST CATALASE TEST |
DIFCO LABORATORIES, INC. |
|
| K842290 |
06/11/1984 |
SPOT TEST NINHYDRIN REAGENTS |
DIFCO LABORATORIES, INC. |
|
| K842375 |
06/18/1984 |
VENOUS CANNULA W/BENT, TIP WIRE |
DLP, INC. |
|
| K842472 |
06/25/1984 |
DRYDEN INFLATABLE MASK |
DRYDEN CORP. |
|
| K842271 |
06/08/1984 |
ELECTRODE, SURFACE EEG ELECTRODE |
DURDEN ENTERPRISES, INC. |
|
| K842386 |
06/18/1984 |
ACA BARBITURATES SCREEN/BENZODIAZEPIN |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
| K842387 |
06/18/1984 |
ACA BENZODIAZEPINES SCREEN TEST PK |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
| K842385 |
06/18/1984 |
ACA CONJUGATED BILIRUBIN ANALYTICAL |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
| K842222 |
06/05/1984 |
DUPONT ACA LIQUID BILIRUBIN CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
| K842220 |
06/05/1984 |
MULTILITH 2 PULSE GENERATOR 1141 & 2141 |
ELA MEDICAL, INC. |
TOM ANDERSON |
| K842193 |
06/04/1984 |
MULTILITH PULSE GENERATORS, 1141 & 2141 |
ELA MEDICAL, INC. |
TOM S ANDERSON |
| K842369 |
06/15/1984 |
ELECATH INFANT ARTERIAL & VENOUS CANNU |
ELECTRO-CATHETER CORP. |
|
| K842391 |
06/18/1984 |
ACR 2500 CARDIOTOMY RESERVOIR FILTER |
ELECTROMEDICS, INC. |
|
| K842211 |
06/04/1984 |
ULTRA CHEM ENZYMATIC TRIGLYCERIDE |
EM DIAGNOSTIC SYSTEMS, INC. |
|
| K842202 |
06/04/1984 |
NEW JERSEY ACETABULAR COMPONENT & |
ENDOMEDICS, INC. |
|
| K842233 |
06/05/1984 |
NEW JERSEY FEMORAL RESURFACING COMPONENT |
ENDOMEDICS, INC. |
|
| K842234 |
06/05/1984 |
NEW JERSEY FEMORAL STEM |
ENDOMEDICS, INC. |
|
| K842436 |
06/20/1984 |
ERIKA NEGATIVE PRESS. ARTERIAL BLOOD |
ERIKA, INC. |
|
| K842478 |
06/25/1984 |
PROLACTIN IRMA |
EURO-DIAGNOSTICS BV |
|
| K842182 |
06/01/1984 |
TITERTEK-ENTEROBAC RAPID AUTOMATED |
FLOW LABORATORIES, INC. |
|
| K842503 |
06/26/1984 |
GAMBRO PULSATILE MONITOR PLM 10-200 |
GAMBRO, INC. |
|
| K842261 |
06/07/1984 |
OB ULTRASOUND LINEAR SCANNER 630 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
|
| K842485 |
06/25/1984 |
OPTICLEAR |
GELMAN SCIENCES, INC. |
|
| K842463 |
06/22/1984 |
GX CEPH |
GENDEX CORP. |
|
| K842307 |
06/12/1984 |
GENERAL DIAG. CEFONICID 30MCG ANTIMIC |
GENERAL DIAGNOSTICS |
|
| K842407 |
06/19/1984 |
PULSED DOPPLER OPTION, CONTINU-WAVE |
GENERAL ELECTRIC CO. |
JAMES M HOWARD |
| K842184 |
06/01/1984 |
SPOT-FILM DEVICE 8835 |
GENERAL ELECTRIC CO. |
|
| K842348 |
06/15/1984 |
SPX GENERATOR |
GENERAL ELECTRIC CO. |
|
| K842500 |
06/26/1984 |
DATA MGMT. SYSTEM |
GILFORD |
|
| K842188 |
06/04/1984 |
MULTIPLE-LENS, SPECTACLES, CUSTOM |
GOLD CADILLAC CO. |
JIMMY LAM |
| K842515 |
06/12/1984 |
SURGICAL HEADLIGHT |
GOOD-LITE CO. |
|
| K842423 |
06/20/1984 |
PARA THERM BATH |
GRIMM SCIENTIFIC INDUSTRIES, INC. |
|
| K842189 |
06/04/1984 |
MULTIPLE LENS, SPECTACLES CUSTOM |
HANMY OPTICAL INDUSTRIAL CO. |
JIMMY LAM |
| K842448 |
06/22/1984 |
BOSWORTH SUPER BOND DENTAL ADHESIVE |
HARRY J. BOSWORTH CO. |
|
| K842207 |
06/04/1984 |
WAKO B.G. PRETEST STRIPS |
HEALTHDYNE, INC. |
|
| K842370 |
06/15/1984 |
PAGE-WRITER INTERPRETIVE CARDIOGRAPH |
HEWLETT-PACKARD CO. |
JAMES F KISTLER |
| K842236 |
06/05/1984 |
PATIENT MONITOR 78354A |
HEWLETT-PACKARD CO. |
LENKE |
| K842449 |
06/22/1984 |
HICHEM ION 2/4 SERUM RANGE CALIBRATOR |
HI CHEM, INC. |
|
| K842450 |
06/22/1984 |
HICHEM ION 2/4 URINE RANGE CALIBRATOR |
HI CHEM, INC. |
|
| K842289 |
06/08/1984 |
SR- MODEL 230 |
HIRATA SANGYO CO. USA, INC. |
|
| K842311 |
06/12/1984 |
CHEMISTRY ANALYZER, GEN. PURPOSE |
HML INC/BIOTECHNOLOGY TRANSFER |
|
| K842310 |
06/12/1984 |
HEMATOLOGY ANALYZER |
HML INC/BIOTECHNOLOGY TRANSFER |
|
| K842192 |
06/04/1984 |
CROUP TENT FRAME |
HOME RUN TREADMILL CO. |
|
| K842367 |
06/15/1984 |
HOWMEDICA KINEMATIC II TIBIAL WEDGE |
HOWMEDICA CORP. |
|
| K842304 |
06/11/1984 |
THE PATHFINDER |
HYDRO-MED PRODUCTS, INC. |
|
| K842268 |
06/08/1984 |
VACUPULSE VACUUM UNIT |
I-REP, INC. |
|
| K842355 |
06/21/1984 |
INFUSAID INFUSE-A-PORT |
INFUSAID CORP. |
|
| K842301 |
06/11/1984 |
DISPOSABLE LATEX BANDAGE |
INMED CORP. |
FLO BECKER |
| K842267 |
06/08/1984 |
C-PEP-RIA-100 |
INSTITUT NATIONAL DES RADIOELEMENTS |
|
| K842339 |
06/13/1984 |
COMPUSTRESS STRESS TESTING SYS |
INTL. MEDICAL, INC. |
JAMES B FREDERICK |
| K842232 |
06/05/1984 |
PLAIN JANE SERIES WHEELCHAIR |
INVACARE CORP. |
|
| K842408 |
06/19/1984 |
IREX 730 MECHANICAL SECTOR SCANNER |
IREX CORP. |
RAYMOND F CHASE |
| K842300 |
06/11/1984 |
ONPG DISKS |
IRVINE DIAGNOSTIC SERVICES |
|
| K842298 |
06/11/1984 |
OXIDASE TEST STRIPS-OXIDASESURE |
IRVINE DIAGNOSTIC SERVICES |
|
| K842299 |
06/11/1984 |
ZINC DUST SUSPENSION |
IRVINE DIAGNOSTIC SERVICES |
|
| K842296 |
06/11/1984 |
ISOSTATION LOWER BACK MACHINE |
ISOTECHNOLOGIES, INC. |
|
| K842210 |
06/04/1984 |
IVENT 302VC DUAL CONTROLLER |
IVENT CORP. |
|
| K842488 |
06/26/1984 |
SAMSON 1000 ANESTHESIA CIRCUIT |
J. H. EMERSON CO. |
|
| K842487 |
06/26/1984 |
SAMSON'S NEWBORN LUNG INFLATOR 340-1000 |
J. H. EMERSON CO. |
|
| K842511 |
06/26/1984 |
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
BARBARA G RAMSEYER |
| K842392 |
06/18/1984 |
DELTON * OPAQUE LIGHT CURING PIT |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
| K842344 |
06/14/1984 |
HASTINGS BIPOLAR ENDOPROSTHESIS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
| K842480 |
06/25/1984 |
SURE & NATURAL MAXI-SHIELD |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
| K842422 |
06/20/1984 |
KONTRON FAX FETAL MONITOR |
KONTRON INSTRUMENTS, INC. |
|
| K842474 |
06/25/1984 |
GLUCOCHEK III |
LARKEN INDUSTRIES, INC. |
KEN ANDERSON |
| K842498 |
06/26/1984 |
DANIELL DBL PUNCTURE LASER LAPAROSCOPY |
LASER SPECTRUM, INC. |
|
| K842235 |
06/05/1984 |
SERVOCARD DEFIBRILLATOR SCP-851 |
LITTON DATAMEDIX |
DAVID O JONES |
| K842312 |
06/12/1984 |
SERVOCARD SCP-840 |
LITTON DATAMEDIX |
DAVID O JONES |
| K842497 |
06/26/1984 |
SERVOMED OXYMONITO SMK 363 |
LITTON DATAMEDIX |
|
| K842368 |
06/15/1984 |
SICKLE CELL REAGENT SET |
LIVONIA DIAGNOSTICS, INC. |
|
| K842225 |
06/05/1984 |
HEMODIAL CONCENTRATE MIXING APPARATUS |
LMF MEDICAL RESEARCH & MANUFACTURING, INC. |
|
| K842313 |
06/12/1984 |
ELVI 146 SEROSCAN |
LOGOS SCIENTIFIC, INC. |
|
| K842345 |
06/14/1984 |
MAXIFILL TRANSFER SET |
LYPHOMED, INC. |
|
| K842277 |
06/08/1984 |
DIMERTEST LATEX |
MABCO, INC. |
WATSON |
| K842464 |
06/25/1984 |
TRACHEAL TUBE/STETHOSCOPE |
MALLINCKRODT CRITICAL CARE |
|
| K842308 |
06/12/1984 |
12SSL-SC |
MARQUETTE ELECTRONICS, INC. |
|
| K842494 |
06/26/1984 |
MATRIS INSTRU. VIDEO IMAGER 1010- |
MATRIX INSTRUMENTS |
|
| K842495 |
06/26/1984 |
MATRIX VIDEO IMAGER 1020 COMPACT CAMER |
MATRIX INSTRUMENTS |
|
| K842342 |
06/14/1984 |
MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN |
MED-WEST, INC. |
|
| K842205 |
06/04/1984 |
OXY-VAC |
MEDI-TECH, INC. |
|
| K842416 |
06/20/1984 |
DUO FLOW CATHETER-MC 54 |
MEDICAL COMPONENTS, INC. |
|
| K842479 |
06/25/1984 |
I.V. TEAMATE |
MEDICAL DELIVERY SYSTEMS |
WILLIAM E MCGLONE |
| K842471 |
06/25/1984 |
AUTOMATED INTRAOCULAR SCISSORS |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
WILLIAM T GEORGE |
| K842305 |
06/12/1984 |
C.A.P.D. AUTOMATIC HEATER PDH 200 |
MEDIONICS INTERNATIONAL LTD. |
|
| K842247 |
06/06/1984 |
MELOY AUTOANTIBODY TEST SYS |
MELOY LABORATORIES, INC. |
|
| K842217 |
06/04/1984 |
IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS |
MICRO CONSULTANTS, INC. |
NATHAN SCHNEIDER |
| K842212 |
06/04/1984 |
MICROMEDICS SURGICAL INSTRUMENTS |
MICROMEDICS, INC. |
|
| K842238 |
06/05/1984 |
CLINITEK 10 SEMI-AUTO URINALYSIS SYS |
MILES LABORATORIES, INC. |
|
| K842237 |
06/05/1984 |
CLINITEK 200 SEMI-AUTOMATED URINALYSIS |
MILES LABORATORIES, INC. |
|
| K842468 |
06/25/1984 |
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG |
MILES LABORATORIES, INC. |
|
| K842470 |
06/25/1984 |
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM |
MILES LABORATORIES, INC. |
|
| K842336 |
06/13/1984 |
DISPOSABLE PILLOW |
MONTEREY MILLS, INC. |
|
| K842335 |
06/13/1984 |
PILLOW W/STAPHCHEK TICKING |
MONTEREY MILLS, INC. |
|
| K842174 |
06/06/1984 |
PERCUTANEOUS GASTROSTOMY TUBE |
MOUNT CARMEL MERCY HOSPITAL |
JASON H BODZIN |
| K842276 |
06/08/1984 |
SUNMASTER |
MT. HOOD MFR., INC. |
|
| K842514 |
06/26/1984 |
ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD |
MULTI BIOSENSORS, INC. |
MANOLI |
| K842224 |
06/05/1984 |
BNS 40 |
MYO-TRONICS RESEARCH, INC. |
FRAY ADIB |
| K842223 |
06/05/1984 |
J4 MYO-MONITOR |
MYO-TRONICS RESEARCH, INC. |
FRAY ADIB |
| K842185 |
06/01/1984 |
PROTEX CONTRACEPT PLUS W/SPERM-LUB |
NATIONAL SANITARY LABORATORIES, INC. |
|
| K842381 |
06/18/1984 |
SLS 3500 LED VISUAL STIMULATOR |
NIHON KOHDEN AMERICA, INC. |
PAUL M PARASHAK |
| K842499 |
06/26/1984 |
NMS 1043 ENZYME IMMUNOASSAY KIT |
NMS PHARMACEUTICALS, INC. |
|
| K842486 |
06/26/1984 |
ELECTRONIC DIGITAL BP METER HC 3001 |
NORTH AMERICAN PHILIPS CORP. |
|
| K842194 |
06/04/1984 |
PRESSURE MONITOR |
NORTON TEXAS MEDICAL PRODUCTS |
RICK FOSTER |
| K842374 |
06/18/1984 |
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
| K842215 |
06/04/1984 |
ASCORBIC ACID |
ORGANON TEKNIKA CORP. |
|
| K842302 |
06/11/1984 |
FLUID WARMER |
ORGANON TEKNIKA CORP. |
|
| K842513 |
06/26/1984 |
HEMOPERFUSION PROCEDURE W/REDY 2000 |
ORGANON TEKNIKA CORP. |
|
| K842314 |
06/12/1984 |
DUOCLON COLOR-CEPT |
ORGANON, INC. |
|
| K842216 |
06/04/1984 |
CULTURESET HSV ISOLATION & ID SYS |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
LARRY D MCCLAIN |
| K842424 |
06/20/1984 |
BIOTIS LD-PRESUMPTO QUADRANT PLATE |
OTISVILLE BIOTECH, INC. |
|
| K842400 |
06/19/1984 |
BIOTIS N.Y.C. CARBOHYDRATE FERMENTA- |
OTISVILLE BIOTECH, INC. |
|
| K842208 |
06/04/1984 |
NATURA-TONE OR LUXOPAL CL ACRYLIC |
PAREXEL INTL. CORP. |
|
| K842187 |
06/04/1984 |
MULTIPLE LENS, SPECTACLES, CUSTOM |
PAVUNA LTD. |
JIMMY LAM |
| K842535 |
06/28/1984 |
PENTAD VOCALIZER |
PENTAD CORP. |
|
| K842371 |
06/15/1984 |
LEE SYRINGE |
PETER F. LEE, INC. |
PETER F LEE |
| K842457 |
06/22/1984 |
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE |
PHARMACIA, INC. |
|
| K842213 |
06/04/1984 |
VSM R1 |
PHYSIO-CONTROL CORP. |
MICHAEL B GROPP |
| K842262 |
06/07/1984 |
PIRD-Y |
PIRDY, INC. |
|
| K842359 |
06/22/1984 |
AUTOMATIC PATIENT CHAIR PM2000 & A |
PLANMECA USA, INC. |
|
| K842358 |
06/22/1984 |
ISOLIGHT |
PLANMECA USA, INC. |
|
| K842357 |
06/22/1984 |
PM 2000 DENTAL UNIT |
PLANMECA USA, INC. |
|
| K842406 |
06/19/1984 |
WESCOTT TYPE BIOPSY NEEDLE |
POPPER & SONS, INC. |
|
| K842456 |
06/22/1984 |
JET VENTILATION ADAPTOR |
PORTEX, INC. |
|
| K842295 |
06/11/1984 |
INTRAUTERINE DEVICE REMOVER |
PREMIER DENTAL PRODUCTS CO. |
WILLIAM J FREZEL |
| K842405 |
06/19/1984 |
DR. GOULD HAND PACK SUSTOM STERIL |
PRO-LAB, INC. |
|
| K842404 |
06/19/1984 |
DRESSING CHANGE TRAY STERILE 5002 |
PRO-LAB, INC. |
DAN MCDONALD |
| K842176 |
06/08/1984 |
RAAF DUAL LUMEN CATHETER |
QUINTON, INC. |
|
| K842414 |
06/19/1984 |
ECHO PULSE BURST |
RABAR, INC. |
|
| K842297 |
06/11/1984 |
ARGINIE BROTH |
REMEL CO. |
|
| K842258 |
06/07/1984 |
RENATRON |
RENAL SYSTEMS, INC. |
|
| K842475 |
06/25/1984 |
RICHARDS INTRA-ARTICULAR SHAVER MOTOR |
RICHARDS MEDICAL CO., INC. |
|
| K842372 |
06/15/1984 |
SPIROMATE AS-500 |
RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP. |
|
| K842483 |
06/25/1984 |
SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC |
SANTA BARBARA MEDCO, INC. |
|
| K842491 |
06/26/1984 |
SDC SILICONE FORCEP SHODS PRODUCT |
SCIENCE DEVELOPMENT CORP. |
|
| K842403 |
06/19/1984 |
LUSTER, DENTAL POLISHING PASTE |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
| K842325 |
06/13/1984 |
CAPNOMETER |
SENSORS, INC. |
|
| K842181 |
06/01/1984 |
BETA-HCG HEMAGGLUTINATION TEST |
SERO-IMMUNO DIAGNOSTICS, INC. |
|
| K842199 |
06/04/1984 |
ELEC. DIGITAL THERMOMETER MT-20 & 30 |
SHARP ELECTRONICS CORP. |
|
| K842200 |
06/04/1984 |
MD308H DIGITAL/MB351H AUTO-BP MONITOR |
SHARP ELECTRONICS CORP. |
GLEN L WEINBERG |
| K842421 |
06/20/1984 |
ARGYLE ENTERITE ENTERAL FEEDING PUMP |
SHERWOOD MEDICAL CO. |
|
| K842337 |
06/05/1984 |
SHILEY VENOUS RESERVOIR |
SHILEY, INC. |
|
| K842366 |
06/15/1984 |
OXALATE URINE CONTROLS NORMAL & ELEVAT |
SIGMA CHEMICAL CO. |
|
| K842411 |
06/19/1984 |
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS |
SIGMA CHEMICAL CO. |
|
| K842384 |
06/18/1984 |
ULTRA-VIOLET EMITTING SUNLAMP PRODUCT |
SOLA-TAN INTL. |
|
| K842334 |
06/13/1984 |
LIFE MONITOR I |
ST. CROIX MEDICAL SYSTEMS, INC. |
|
| K842356 |
06/15/1984 |
CUSTOM STERILE PROCEDURE KITS |
STERILE DESIGN, INC. |
JOHN C HOFFMAN |
| K842351 |
06/15/1984 |
STERILE DESIGN-CUSTOM STERILE IV KIT |
STERILE DESIGN, INC. |
JOHN C HOFFMAN |
| K842521 |
06/27/1984 |
AST/GOT REAGENT SET UV RATE |
STERLING BIOCHEMICAL, INC. |
|
| K842275 |
06/08/1984 |
ULTRASONIC COOL SPRAY HUMIDIFIER |
SUNBEAM CORP. |
|
| K842444 |
06/21/1984 |
FSH RIA |
SYNCOR INTL. CORP. |
|
| K842445 |
06/21/1984 |
LH RIA |
SYNCOR INTL. CORP. |
|
| K842598 |
06/21/1984 |
STAR HCG MONOCLONAL ANTIBODY IMMUNO |
SYNCOR INTL. CORP. |
|
| K842390 |
06/18/1984 |
SYVA IQ 190 DIGITAL PIPETTER DILUTER |
SYVA CO. |
|
| K842388 |
06/18/1984 |
COPAL DIGITAL SPHYGMOMANOMETER UA-510 |
TAKEDA MEDICAL, INC. |
HUGH NAMEKAWA |
| K842230 |
06/05/1984 |
AIMED DISPOS. INJECTION NEEDLE |
TECH-CONS LTD., INTL. |
|
| K842227 |
06/05/1984 |
AIMED DISPOSABLE SYRINGE, VARIOUS SIZES |
TECH-CONS LTD., INTL. |
|
| K842228 |
06/05/1984 |
AIMED FOLEY CATHETER VARIOUS SIZES |
TECH-CONS LTD., INTL. |
|
| K842255 |
06/07/1984 |
AIMED SCALP VEIN SET VARIOUS |
TECH-CONS LTD., INTL. |
|
| K842473 |
06/25/1984 |
IMPLANTABLE PROGRAMMABLE PULSE GENERAT |
TELECTRONICS, INC. |
WILLIAM C NEALON |
| K842493 |
06/26/1984 |
AGEE EXTERNAL FIXATOR |
THE HAND BIOMECHANICS RESEARCH LABORATORY |
|
| K842496 |
06/26/1984 |
ICP/6500 INDUCTIVELY-COUPLED PLASMA- |
THE PERKIN-ELMER CORP. |
|
| K842461 |
06/22/1984 |
TONGUE DEPRESSOR |
THE TORRENT CORP. |
GARY L SWANSON |
| K842399 |
06/19/1984 |
48 HOUR SET CHANGES |
TRI-MED, INC. |
ARDEN P MORLEY |
| K842315 |
06/12/1984 |
ULTRA LYTE ANALYZER I 100 |
ULTRA QUEST DIAGNOSTICS, INC. |
|
| K842259 |
06/07/1984 |
PCI W/CATH-SEAL SIDE FLOW FITTING |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
|
| K842352 |
06/15/1984 |
PRESSURE MONITORING KIT |
UTAH MEDICAL PRODUCTS, INC. |
EDWIN O GOODMAN |
| K842460 |
06/22/1984 |
VF-PD-120 |
VALPEY-FISHER CORP. |
RAN RUBIN |
| K842191 |
06/04/1984 |
DIGISTORE 50 |
VAS CORP. |
KAREN A BARON |
| K842239 |
06/05/1984 |
VENTRESCREEN STREP A TEST |
VENTREX LABORATORIES, INC. |
|
| K842264 |
06/07/1984 |
VENTREZYME PHENOBARBITAL KIT IMMUNO |
VENTREX LABORATORIES, INC. |
|
| K842309 |
06/12/1984 |
VITACOMM 100 ESOPHAGEAL STETHOSCOPE |
VITACOMM, INC. |
|
| K842452 |
06/22/1984 |
WAKO LDH CII TEST |
WAKO CHEMICALS, USA, INC. |
|
| K842221 |
06/05/1984 |
WAKO GLUCOSE C |
WAKO PURE CHEMICAL INDUSTRIES, LTD. |
|
| K842254 |
06/07/1984 |
MEDICAL EMERG. STABILIZER OBJECT/BODY |
WALTER ANSTED CO. |
|
| K842379 |
06/18/1984 |
ELECTRO-SAGE MODEL 203 |
WEINGART, INC. |
|
| K842419 |
06/20/1984 |
IVAC 280 VOLUMETRIC INFUSION CONTROLLER |
Y |
|
| K842317 |
06/12/1984 |
SIGNAL ELECTRONIC CLINICAL THERMOMETER |
YUKOSHA CO., INC. |
|
| K842318 |
06/12/1984 |
YKI-770 ELECTRONIC SPHYGMOMAMETER |
YUKOSHA CO., INC. |
|
| K842501 |
06/26/1984 |
TSS/FIK |
ZARCON CORP. |
CHARLES E KIMBLE |
| K842263 |
06/07/1984 |
MTP E.V. INFUSION PUMP |
ZIEHM INTERNATIONAL, INC. |
|
| K842343 |
06/14/1984 |
SABA-COOMBS MINI EXTERNAL FIXATOR |
ZIMMER, INC. |
|
