FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K834360 |
12/13/1983 |
3-D PASSIVE MOBILIZER |
3-D ORTHOPEDIC, INC. |
|
K834464 |
12/20/1983 |
TDX PROCAINAMIDE |
ABBOTT LABORATORIES |
|
K834350 |
12/13/1983 |
ACUFEX DREZ COMMUNICATING DRILL GUIDE |
ACUFEX MICROSURGICAL, INC. |
|
K834369 |
12/13/1983 |
CRANE MENISCAL SUTURE SET |
ACUFEX MICROSURGICAL, INC. |
|
K834370 |
12/13/1983 |
MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER |
ACUFEX MICROSURGICAL, INC. |
|
K834206 |
12/05/1983 |
EUGONIC AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K834205 |
12/05/1983 |
MIDDLEBROOK & COHN 7H10 AGAR BASE |
ACUMEDIA MANUFACTURERS, INC. |
|
K834204 |
12/05/1983 |
MIDDLEBROOK & COHN 7H11 AGAR BASE |
ACUMEDIA MANUFACTURERS, INC. |
|
K834141 |
12/21/1983 |
ULTRASOUND SCAN HEAD 3.5 MHZ |
ADR ULTRASOUND |
|
K834433 |
12/07/1983 |
PTCA BALLOON CATHETERS & ACCESS. |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
|
K834270 |
12/08/1983 |
ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST |
ADVANCED CARE PRODUCTS |
|
K834573 |
12/29/1983 |
AQUA TRAP |
AIRLIFE, INC. |
|
K834570 |
12/29/1983 |
VOLUME VENTILATOR CIRCUIT W/WATER TRAP |
AIRLIFE, INC. |
|
K834405 |
12/14/1983 |
TEC TRACTION MACHINE |
AKRON MEDICAL CORP. |
|
K834272 |
12/08/1983 |
ALEXOLOK BRACKET |
ALEXOTEK CO. |
|
K834446 |
12/16/1983 |
ALEXOTEK LINGUAL TUBES |
ALEXOTEK CO. |
|
K834392 |
12/14/1983 |
LABIAL CUSPID TUBE |
ALEXOTEK CO. |
|
K834244 |
12/07/1983 |
THEOFAST TEST KIT FOR QUANTITATIVE THEO |
ALLERGENETICS |
|
K834594 |
12/29/1983 |
TOTAL IGE FAST TEST |
ALLERGENETICS |
|
K834376 |
12/14/1983 |
FILTRARE TM ALLVENT TM |
ALLTEK, INC. |
|
K834373 |
12/12/1983 |
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 |
AMERICAN BENTLEY |
|
K834209 |
12/05/1983 |
STRATUS THYROID UPTAKE FLUOROMETRIC |
AMERICAN DADE |
|
K834210 |
12/05/1983 |
STRATUS TOTAL THYROXINE FLUOROMETRIC |
AMERICAN DADE |
|
K834547 |
12/27/1983 |
ANGIOSCOPY CATHETER |
AMERICAN EDWARDS LABORATORIES |
|
K834459 |
12/19/1983 |
DIAGNOSTIC RADIOLOGY CATHETERS |
AMERICAN EDWARDS LABORATORIES |
|
K834220 |
12/05/1983 |
HYBRID PERIPHERAL DILATION CATHETER |
AMERICAN EDWARDS LABORATORIES |
|
K834429 |
12/15/1983 |
PERIPHERAL DILATATION ANGIOPLASTY-CATH |
AMERICAN EDWARDS LABORATORIES |
|
K834145 |
12/01/1983 |
ERGO DIAGNOSTIC CARD |
AMERICAN ERGO SYSTEMS |
|
K834593 |
12/29/1983 |
ONE-PIECE SHUNT |
AMERICAN HEYER SCHULTE |
|
K834251 |
12/07/1983 |
HDL CHOLESTEROL PRETREATMENT |
AMERICAN MONITOR CORP. |
|
K834248 |
12/07/1983 |
PARALLEL FLAME PHOTOMETER & SODIUM |
AMERICAN MONITOR CORP. |
|
K834336 |
12/12/1983 |
FLOW-PAC CALCIUM REAGENT SET |
AMERICAN RESEARCH PRODUCTS CO. |
|
K834333 |
12/12/1983 |
FLOW-PAC CHLORIDE REAGENT SET |
AMERICAN RESEARCH PRODUCTS CO. |
|
K834507 |
12/21/1983 |
HYDROPULSE(GROSSAN);INFLAT TUBE MASS |
AMREX-ZETRON, INC. |
|
K834357 |
12/13/1983 |
ANA TRANS TUBE & SWABS STERILE PACK |
ANAEROBE SYSTEMS |
|
K834275 |
12/08/1983 |
SOFTIP CATHETER |
ANGIOMEDICS, INC. |
|
K834242 |
12/06/1983 |
ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS |
APPLE DIAGNOSTIC PRODUCTS |
|
K834241 |
12/06/1983 |
ANA APPLELISA |
APPLE DIAGNOSTIC PRODUCTS |
|
K834264 |
12/08/1983 |
REVERSE-FLOW SYSTEM |
APPLIED POLYTECHNOLOGY, INC. |
|
K834155 |
12/02/1983 |
UNIVERSAL PACK |
ATLANTIC OPTICAL SYSTEMS, INC. |
|
K834601 |
12/30/1983 |
AVL MODEL 945 BLOOD GAS SYSTEM |
AVL SCIENTIFIC CORP. |
|
K834509 |
12/21/1983 |
ACETAMIDE AGAR SLANTS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K834480 |
12/20/1983 |
INJECTION CAP |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K834553 |
12/27/1983 |
INTRADISCAL THERAPY TRAY |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K834555 |
12/27/1983 |
BEAR VENTI--VOICE |
BEAR MEDICAL SYSTEMS, INC. |
|
K834595 |
12/30/1983 |
PARAGON ACID HEMOGLOBIN REAGENT KIT |
BECKMAN INSTRUMENTS, INC. |
|
K834344 |
12/12/1983 |
MED-OPEDIC SLEEP SYSTEM |
BEMCO MATTRESS CO. |
|
K834500 |
12/21/1983 |
SOLUTION TRANSFER SET |
BERLEX LABORATORIES, INC. |
|
K834398 |
12/14/1983 |
LIQUI-SERA TDM CALIBRATORS |
BIO DIAGNOSTIC INTL. |
|
K834259 |
12/07/1983 |
LIQUI-URA TOXIC URINE CONTROL |
BIO DIAGNOSTIC INTL. |
|
K834301 |
12/09/1983 |
THROMBOLYTIC ACTIVITY TEST |
BIO/DATA CORP. |
|
K834474 |
12/20/1983 |
H.P.T. HOME PREG. TEST KIT & A.P.T. |
BIOMEDICAL RESEARCH & DEVELOPMENT LABORATORIES INC |
|
K834268 |
12/08/1983 |
ISLAMI GASTROINTESTINAL TUBE |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K834403 |
12/14/1983 |
INJECTION NEEDLE |
BOBBS MEDICAL, INC. |
|
K834271 |
12/08/1983 |
REFLOCHECK & GLUCOSE TEST STRIP SYS |
BOEHRINGER MANNHEIM CORP. |
|
K834503 |
12/21/1983 |
PROFILE URODYNAMIC MONITORING SYS |
BROWNE MEDICAL, INC. |
|
K834384 |
12/14/1983 |
MODULAR EXTREMITY CASTING SUPPORT |
BUCKMAN CO., INC. |
|
K834506 |
12/21/1983 |
PACESAVER & SCOUT |
BURKE, INC. |
|
K834383 |
12/14/1983 |
DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT |
BURRON MEDICAL PRODUCTS, INC. |
|
K834299 |
12/08/1983 |
LONG TERM CENTRAL VENOUS ACCESS CATH |
BURRON MEDICAL PRODUCTS, INC. |
|
K834473 |
12/20/1983 |
MULTI-LUMEN CENTRAL VENOUS CATH. KIT |
BURRON MEDICAL PRODUCTS, INC. |
|
K834575 |
12/29/1983 |
BARD KARAYA GUM WASHERS |
C.R. BARD, INC. |
|
K834438 |
12/19/1983 |
TEMPERATURE SENSING FOLEY CATHETER |
C.R. BARD, INC. |
|
K834574 |
12/29/1983 |
USCI ENDOPROSTHESIS |
C.R. BARD, INC. |
|
K834146 |
12/01/1983 |
ANTHROSCOPY SYSTEM |
CABOT MEDICAL CORP. |
|
K834152 |
12/01/1983 |
ETHYLENE OXIDE DETECTOR GLD-1-07 |
CALNOR OF EL PASEO, INC. |
|
K834342 |
12/12/1983 |
CCS MODEL AV-102 IMPLANTABLE A-V DATA |
CARDIAC CONTROL SYSTEMS, INC. |
|
K834257 |
12/07/1983 |
CARDIODATA PACE RECORDER |
CARDIO DATA |
|
K834611 |
12/20/1983 |
SINGUL-XR RP NON SCREEN MED. FILM |
CEA AMERICA CORP. |
|
K834613 |
12/20/1983 |
WILCOR-XR RP MEDICAL FILM |
CEA AMERICA CORP. |
|
K834614 |
12/20/1983 |
WILCOR-XR RP-L MEDICAL FILM |
CEA AMERICA CORP. |
|
K834612 |
12/20/1983 |
WILCOR-XR RP-OG MEDICAL FILM |
CEA AMERICA CORP. |
|
K834588 |
12/29/1983 |
OXYMIZER-PENDANT |
CHAD THERAPEUTICS, INC. |
|
K834475 |
12/20/1983 |
RESPIRODYNE PULMONARY FUNCTION TEST |
CHESEBROUGH-POND'S U.S.A. CO. |
|
K834340 |
12/12/1983 |
IOCARE IRRIGATION & ASPIRATION PACK |
CHIRON VISION CORP. |
|
K834465 |
12/20/1983 |
SERIES OF DIAGNOSTIC PHANTOMS |
CIRS, INC. |
|
K834477 |
12/20/1983 |
DISPOS. SCOTT CANNULAS 16-1054 ETC. |
CODMAN & SHURTLEFF, INC. |
|
K834343 |
12/12/1983 |
COMFEEL POWDER |
COLOPLAST A/S |
|
K834337 |
12/12/1983 |
URIHESIVE SYSTEM - IMPROVED |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
K834548 |
12/27/1983 |
HYPODERMIC SYRINGES & NEEDLES |
CORDIS CORP. |
|
K834416 |
12/15/1983 |
LUMELEC ELECTRODE CATHETER |
CORDIS CORP. |
|
K834508 |
12/21/1983 |
CORNING 4000 MULTI-WELL GAMMA COUNTER |
CORNING MEDICAL & SCIENTIFIC |
|
K834568 |
12/29/1983 |
COULTER COUNTER M2 |
COULTER ELECTRONICS, INC. |
|
K834569 |
12/29/1983 |
VENTILATORY FREQUENCY MONITOR |
CRYO CORP. |
|
K834558 |
12/28/1983 |
CK10000 SERIES POUCH & BAGS ETC. |
CURRIE MEDICAL SPECIALTIES, INC. |
|
K834504 |
12/21/1983 |
ESKA JONAS SILICON-SILVER PENILE |
DACOMED CORP. |
|
K834534 |
12/22/1983 |
APSARA ANALYZER |
DATACHEM, INC. |
|
K834409 |
12/14/1983 |
DENTURE BASE RESIN |
DENTSPLY INTL. |
|
K834142 |
12/01/1983 |
ADHESIVE TRACTION TAPE |
DEVON INDUSTRIES, INC. |
|
K834135 |
12/01/1983 |
STERILE SUTURE BOOTS |
DEVON INDUSTRIES, INC. |
|
K834395 |
12/14/1983 |
CHEMLYTE |
DIACHEM LABORATORIES |
|
K834346 |
12/12/1983 |
BHCG-CHECK |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K834345 |
12/12/1983 |
IM-CHECK |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K834372 |
12/01/1983 |
PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K834571 |
12/29/1983 |
FIBRINOGEN TEST |
DIATECH, INC. |
|
K834582 |
12/29/1983 |
DETECT GROUP A STREP TEST |
DIFCO LABORATORIES, INC. |
|
K834581 |
12/29/1983 |
DIFFERENTIATION DISKS HIPPURATE |
DIFCO LABORATORIES, INC. |
|
K834352 |
12/13/1983 |
ADULT VENT CATHETER |
DLP, INC. |
|
K834576 |
12/29/1983 |
REAL FIBER OPTIC URETERAL TRANSILLUMIN |
DOUGLAS MANUFACTURER CO. |
|
K834226 |
12/06/1983 |
FLAME PHOTOMETERS |
DR. BRUNO LANGE GMBH |
|
K834484 |
12/01/1983 |
CRONEX SR-337 |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K834521 |
12/21/1983 |
DISCRETE CLINICAL ANALYZER |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K834335 |
12/12/1983 |
AMEDA PHOTOTHERAPY LAMP FOR NEWBORN |
EGNELL, INC. |
|
K834293 |
12/08/1983 |
ELECTRONIC CELL ENERGIZER |
ELECTRONIC ENERGY, INC. |
|
K834164 |
12/01/1983 |
SPINAL NEEDLES & ACCESSORY |
ELFA TRADING CO. |
|
K834165 |
12/01/1983 |
SYRINGE |
ELFA TRADING CO. |
|
K834496 |
12/08/1983 |
ISOREX LS-36 |
ELSCINT, INC. |
|
K834294 |
12/08/1983 |
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB |
EMD CHEMICALS INC. |
|
K834487 |
12/13/1983 |
FLEXIBLE LIQUID LIGHT GUIDE |
ENDO LASE, INC. |
|
K834267 |
12/08/1983 |
LIGACLIP METALLIC LIGATING CLIP |
ETHICON, INC. |
|
K834554 |
12/27/1983 |
ETHOX WEIGHTED FEEDING TUBE |
ETHOX CORP. |
|
K834552 |
12/27/1983 |
PREMIER |
EVEREST & JENNINGS, INC. |
|
K834462 |
12/19/1983 |
GENUCOM |
FAR ORTHOPEDICS, INC. |
|
K834453 |
12/19/1983 |
PHACO FRAGMENTOR GT-1 |
FIBRA SONICS, INC. |
|
K834546 |
12/27/1983 |
SURGICAL KNIFE |
FINE-CUT DIAMOND INSTRUMENTS |
|
K834577 |
12/29/1983 |
I/A PROBE LINES |
FRIGITRONICS OF CONNECTICUT, INC. |
|
K834437 |
12/19/1983 |
KEATES IRRIGATION/ASPIRATION/VITREOUS |
FRIGITRONICS OF CONNECTICUT, INC. |
|
K834535 |
12/22/1983 |
NITROUS OXIDE RECYCLER |
G & L UNLTD. |
|
K834440 |
12/19/1983 |
INJECTION AIDE UNIT FOR DIAGETICS |
GOTTINGER CO. |
|
K834445 |
12/16/1983 |
MEDI-TRACE QUIKSET DX DIAG. ELECT- |
GRAPHIC CONTROLS CORP. |
|
K834455 |
12/19/1983 |
MONOXYCHLOROSENE WAREXIN |
GUARDIAN CHEMICAL |
|
K834616 |
12/14/1983 |
AMNIO STAT-FLM AGGLUTINATION TEST |
HANA BIOLOGICS, INC. |
|
K834319 |
12/09/1983 |
BHI AGAR |
HARDY MEDIA |
|
K834318 |
12/09/1983 |
BRUCELLA W/H & K |
HARDY MEDIA |
|
K834313 |
12/09/1983 |
CAMPY 3 |
HARDY MEDIA |
|
K834314 |
12/09/1983 |
CAMPY 5 |
HARDY MEDIA |
|
K834326 |
12/09/1983 |
CAMPY 5H |
HARDY MEDIA |
|
K834327 |
12/09/1983 |
CIN AGAR |
HARDY MEDIA |
|
K834322 |
12/09/1983 |
EMMON 3 SABDEX |
HARDY MEDIA |
|
K834325 |
12/09/1983 |
INHIBITORY MOLD AGAR |
HARDY MEDIA |
|
K834323 |
12/09/1983 |
POTATO DEXTROSE AGAR |
HARDY MEDIA |
|
K834317 |
12/09/1983 |
SELENITE BROTH |
HARDY MEDIA |
|
K834315 |
12/09/1983 |
STERILE SALINE 0.85% |
HARDY MEDIA |
|
K834320 |
12/09/1983 |
TCBS |
HARDY MEDIA |
|
K834321 |
12/09/1983 |
THIO W/SUPPLEMENT |
HARDY MEDIA |
|
K834324 |
12/09/1983 |
TSA |
HARDY MEDIA |
|
K834316 |
12/09/1983 |
WATER W/TWEEN 80 |
HARDY MEDIA |
|
K834456 |
12/19/1983 |
HELENA BIO STRIP OB |
HELENA LABORATORIES |
|
K834371 |
12/13/1983 |
TRI-COUNT 10 |
HEMATOLOGY MARKETING ASSOC. |
|
K834598 |
12/30/1983 |
LIGHT TEST |
HEMOGENETICS, INC. |
|
K834338 |
12/12/1983 |
MYCOPLASMA PNEUMONIAE CF ANTIGEN |
HILLCREST BIOLOGICALS |
|
K834351 |
12/13/1983 |
BILIARY INDWELLING STENT |
HOBBS MEDICAL, INC. |
|
K834413 |
12/15/1983 |
DILATION BALLOON CATHETER |
HOBBS MEDICAL, INC. |
|
K834414 |
12/15/1983 |
ERCP CANNULA |
HOBBS MEDICAL, INC. |
|
K834402 |
12/14/1983 |
GASTROINTESTINAL SHEATH BRUSH |
HOBBS MEDICAL, INC. |
|
K834401 |
12/14/1983 |
URETERAL DOUBLE PIGTAIL STENT |
HOBBS MEDICAL, INC. |
|
K834530 |
12/21/1983 |
EXTENSION BOX EB200 |
HONEYWELL, INC. |
|
K834589 |
12/29/1983 |
BIOSPAL (R) 1800S |
HOSPAL MEDICAL CORP. |
|
K834579 |
12/29/1983 |
BIOSPAL 2400S |
HOSPAL MEDICAL CORP. |
|
K834399 |
12/14/1983 |
NEW MOTHER'S WAY-BREAST PUMP |
HUNTLEIGH TECHNOLOGY, INC. |
|
K834300 |
12/09/1983 |
HYBRITECH DATA STATION |
HYBRITECH, INC. |
|
K834407 |
12/14/1983 |
STERILE DISPOSABLE SPINAL NEEDLES |
HYDRO-MED PRODUCTS, INC. |
|
K834540 |
12/01/1983 |
OP-CON SURGICAL INSTRUMENT #9 |
IMM ENTERPRISES LTD. |
|
K834390 |
12/14/1983 |
IMMUNO-CRP |
IMMUNOSTICS CO., INC. |
|
K834391 |
12/14/1983 |
IMMUNO-RA |
IMMUNOSTICS CO., INC. |
|
K834258 |
12/07/1983 |
HODGE DECOMPRESSION TUBE |
INMED CORP. |
|
K834290 |
12/08/1983 |
INSPIRON LIQUID OXYGEN SYSTEM |
INSPIRON CORP. |
|
K834397 |
12/14/1983 |
HOLTER CARDIOGRAPHY SYS 6201 |
INSTRUMENTS FOR CARDIAC RESEARCH |
|
K834488 |
12/14/1983 |
MERRITTAN SUN SYSTEM |
INTERFIT A.G. DBA/INT'L TANNING SYS |
|
K834543 |
12/08/1983 |
OCUCARE ULTRASOUND TIP & FREEDOM PACK |
INTERMEDICS INTRAOCULAR, INC. |
|
K834584 |
12/29/1983 |
NABI CRP-Q.S. TEST |
INTL. DIAGNOSTIC, INC. |
|
K834143 |
12/01/1983 |
NYLON COMPRESSION STUMP SHEATH |
IPOS LUNEBURG |
|
K834517 |
12/21/1983 |
JAY CUSHION |
JAY MEDICAL, LTD. |
|
K834356 |
12/13/1983 |
EYE SPONGE OR SPEAR |
JEDMED INSTRUMENT CO. |
|
K834355 |
12/13/1983 |
MICRO FORCEPS |
JEDMED INSTRUMENT CO. |
|
K834354 |
12/13/1983 |
OPHTEC RUST RING REMOVER |
JEDMED INSTRUMENT CO. |
|
K834560 |
12/28/1983 |
VITEX P.D.A |
JENERIC IND. |
|
K834580 |
12/29/1983 |
REACH* TOOTHBRUSH |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K834302 |
12/09/1983 |
STAYFREE* DEODORANT MAXI-PADS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K834563 |
12/28/1983 |
EGERTON TURNING & TILTING BED |
KINETIC CONCEPTS, INC. |
|
K834559 |
12/28/1983 |
DELUXE WALL-MOUNTED CEPHALOMETER |
KNOCHEN DENTAL LABORATORY |
|
K834606 |
12/28/1983 |
X-RAY COLLIMATOR X-CJD |
KNOCHEN DENTAL LABORATORY |
|
K834150 |
12/01/1983 |
STRIP SPLITTER II -HALF WIDTH CARRIER |
LARKEN INDUSTRIES, INC. |
|
K834586 |
12/29/1983 |
LEECO E2 QUANT DIAG. TEST KIT |
LEECO DIAGNOSTICS, INC. |
|
K834348 |
12/13/1983 |
LEECO T3-QUANT DIAG. KIT |
LEECO DIAGNOSTICS, INC. |
|
K834572 |
12/29/1983 |
EPITRON SUPER |
LEO UNLIMITED, INC. |
|
K834441 |
12/16/1983 |
BLOOD PRESSURE MONITOR BP600X |
LIFELINE SYSTEMS, INC. |
|
K834443 |
12/16/1983 |
ROTAVIRUS BIO-ENZABEAD SCREEN KIT |
LITTON BIONETICS |
|
K834600 |
12/30/1983 |
RECOMB ECG PREAMPLIFIER/206 069 03 |
LITTON MEDICAL ELECTRONICS |
|
K834490 |
12/06/1983 |
GELSCAN SOFTWARE 2190 |
LKB INSTRUMENTS, INC. |
|
K834489 |
12/02/1983 |
ULTROSPEC W/APPLE II -4050- |
LKB INSTRUMENTS, INC. |
|
K834223 |
12/06/1983 |
CARDIOVASCULAR SPRING GUIDE WIRE |
MALLINCKRODT CRITICAL CARE |
|
K834368 |
12/21/1983 |
SURGICAL DISPOSABLE STERILE & NONSTERIL |
MARBEX, INC. |
|
K834526 |
12/21/1983 |
MAST INHALANT PROFILE |
MAST IMMUNOSYSTEMS |
|
K834499 |
12/20/1983 |
SHEATHS FOR REINFORCING BONE CEMENT |
MECRON MEDICAL PRODUCTS, INC. |
|
K834219 |
12/05/1983 |
PHASE II CORTISOL KIT |
MEDICAL & SCIENTIFIC DESIGNS, INC. |
|
K834518 |
12/21/1983 |
LIQUID STABLE TRIGLYCERIDES REAGENT SET |
MEDICAL ANALYSIS SYSTEMS, INC. |
|
K834615 |
12/04/1983 |
TRIPLE LUMEN INFUSIONCATHETERS- |
MEDICAL COMPONENTS, INC. |
|
K834537 |
12/09/1983 |
MICRO VIT FRAGMENTATION SYSTEM |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
|
K834610 |
12/21/1983 |
LASER LENS-VARIOUS MODELS |
MEDITEC OF AMERICA |
|
K834447 |
12/16/1983 |
ECHO MM1000 |
MESA MEDICAL, INC. |
|
K834590 |
12/29/1983 |
ACCUFLEX |
MICROMEDIC SYSTEMS |
|
K834262 |
12/08/1983 |
TRANS-PACE |
MICROMEDICAL DEVICES, INC. |
|
K834468 |
12/20/1983 |
DRAINAGE STENT |
MICROVASIVE |
|
K834467 |
12/20/1983 |
SPECIMEN TRAP |
MICROVASIVE |
|
K834587 |
12/29/1983 |
HEMODIAL CONCENTRATE |
MOANA PRODUCTIONS, INC. |
LETANE M FONOTI |
K834228 |
12/06/1983 |
LITHOTRIPTOR ELECTRODE 4.5F |
MONAGHAN MEDICAL CORP. |
WILLIAM R SHENE |
K834400 |
12/14/1983 |
FLYNN III-CHILD BAG-MASK UNIT ETC |
O-TWO SYSTEMS INTL., INC. |
|
K834410 |
12/15/1983 |
DOUBLE-COAGULATION SWITCHPEN 757 |
OLSEN ELECTRO-SURGICAL INSTRUMENTS, INC. |
|
K834329 |
12/12/1983 |
OLSEN 756 ROCKER SWITCHPEN |
OLSEN ELECTRO-SURGICAL INSTRUMENTS, INC. |
|
K834449 |
12/19/1983 |
HSV ANTIGEN ELISA KIT |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K834417 |
12/15/1983 |
CAMPY BRUCELLA AGAR PLATE |
OTISVILLE BIOTECH, INC. |
|
K834418 |
12/15/1983 |
CDC ANAEROBE BLOOD AGAR PLATE |
OTISVILLE BIOTECH, INC. |
|
K834419 |
12/15/1983 |
COLUMBIA CNA AGAR PLATE |
OTISVILLE BIOTECH, INC. |
|
K834425 |
12/15/1983 |
CTA MEDIUM TUBE |
OTISVILLE BIOTECH, INC. |
|
K834426 |
12/15/1983 |
LOEFFLER MEDIUM TUBE |
OTISVILLE BIOTECH, INC. |
|
K834420 |
12/15/1983 |
MANNITOL-SALT AGAR USP PLATE |
OTISVILLE BIOTECH, INC. |
|
K834421 |
12/15/1983 |
MUELLER-HINTON AGAR PLATE |
OTISVILLE BIOTECH, INC. |
|
K834422 |
12/15/1983 |
PHENYLETHYL ALCOHOL AGAR PLATE |
OTISVILLE BIOTECH, INC. |
|
K834423 |
12/15/1983 |
S S AGAR PLATE |
OTISVILLE BIOTECH, INC. |
|
K834424 |
12/15/1983 |
SFP AGAR PLATES |
OTISVILLE BIOTECH, INC. |
|
K834427 |
12/15/1983 |
THIOGEL MEDIUM TUBE |
OTISVILLE BIOTECH, INC. |
|
K834431 |
12/16/1983 |
PACING ELECTRODE |
PACESETTER SYSTEMS |
|
K834380 |
12/14/1983 |
PALL EC PLUS FILTER |
PALL BIOMEDICAL PRODUCTS CO. |
|
K834382 |
12/14/1983 |
PALL EC PLUS FILTER W/FILTER SLEEVE |
PALL BIOMEDICAL PRODUCTS CO. |
|
K834292 |
12/08/1983 |
PALL HEAT MOISTURE EXCHANGING FILTER |
PALL BIOMEDICAL PRODUCTS CO. |
|
K834381 |
12/13/1983 |
POSIDYNE I.V. FILTER/AIR ELIMINATOR |
PALL BIOMEDICAL PRODUCTS CO. |
|
K834334 |
12/12/1983 |
MEDAID DUAL CHANNEL TENS |
PAR MEDEX LTD. |
|
K834472 |
12/20/1983 |
DESERET EPIDURAL CATHETER |
PARKE-DAVIS CO. |
|
K834393 |
12/14/1983 |
DESERET NEONATAL CATHETER SET |
PARKE-DAVIS CO. |
|
K834227 |
12/06/1983 |
DESERET SUBCLAVIAN JUGULAR CATH. SET |
PARKE-DAVIS CO. |
|
K834461 |
12/19/1983 |
INFUSION PUMP PRIMER |
PARKER HANNIFIN CORP. |
|
K834252 |
12/07/1983 |
PBC EXTENSION SET |
PHILADELPHIA BIOLOGICS CENTER |
|
K834253 |
12/07/1983 |
PBC IV SET NON-VENTED |
PHILADELPHIA BIOLOGICS CENTER |
|
K834254 |
12/07/1983 |
PBC IV SET VENTED |
PHILADELPHIA BIOLOGICS CENTER |
|
K834255 |
12/07/1983 |
PBC SCALP VEIN SET |
PHILADELPHIA BIOLOGICS CENTER |
|
K834256 |
12/07/1983 |
PBC SYRINGE IRRIGATING |
PHILADELPHIA BIOLOGICS CENTER |
|
K834211 |
12/05/1983 |
LEAP FROG |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K834212 |
12/05/1983 |
N-CHANNEL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K834565 |
12/28/1983 |
ENDOBRONCHIAL TWIN LUMEN TUBE |
PORTEX, INC. |
|
K834260 |
12/07/1983 |
RECON-2 FLOW CONTROLLER |
PRECISION METERING, INC. |
|
K834412 |
12/15/1983 |
PRESERV PVA FIXATIVE 15ML-FORMALIN PK |
PREVENTIVE DIAGNOSTICS CORP. |
|
K834566 |
12/28/1983 |
PRESERV SAF FIXATIVE 15ML |
PREVENTIVE DIAGNOSTICS CORP. |
|
K834564 |
12/28/1983 |
MENSTRUAL PADS |
PROBEL-U.S., INC. |
|
K834296 |
12/08/1983 |
ADULT INCONTINENCE BRIEF |
PROCTER & GAMBLE MFG. CO. |
|
K834295 |
12/08/1983 |
ADULT INCONTINENCE PAD |
PROCTER & GAMBLE MFG. CO. |
|
K834339 |
12/12/1983 |
BOUNDARY REINFORCED SINGLE-USE GOWNS |
PROCTER & GAMBLE MFG. CO. |
|
K834332 |
12/12/1983 |
BOUNDARY SINGLE-USE GOWNS |
PROCTER & GAMBLE MFG. CO. |
|
K834131 |
12/01/1983 |
SCENTED MENSTRUAL PAD |
PROCTER & GAMBLE MFG. CO. |
|
K834144 |
12/01/1983 |
UNSCENTED MENSTRUAL PAD |
PROCTER & GAMBLE MFG. CO. |
|
K834478 |
12/20/1983 |
CHICK/REISON PATIENT EMERG. TROLLEY |
PROFESSIONAL MEDICAL PRODUCTS, INC. |
|
K834353 |
12/13/1983 |
OK FLASH STERILIZATION INDICATOR |
PROPPER MFG. CO., INC. |
|
K834297 |
12/08/1983 |
PROPPER SERACULT |
PROPPER MFG. CO., INC. |
|
K834203 |
12/05/1983 |
FLEXXR* CPM SYSTEM |
QAREX LABORATORIES, INC. |
|
K834505 |
12/21/1983 |
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID |
QUANTIMETRIX CORP. |
|
K834528 |
12/21/1983 |
MODEL 2001 INTELLIGENT INFUSOR |
QUEST MEDICAL, INC. |
|
K834583 |
12/29/1983 |
CLEAR LEADS-RADIOTRANSPARENT WIRES |
QUINTON, INC. |
|
K834567 |
12/28/1983 |
Q3000 |
QUINTON, INC. |
|
K834225 |
12/06/1983 |
RAAF DUAL LUMEN CATH. REPAIR KIT 2.2 |
QUINTON, INC. |
|
K834585 |
12/29/1983 |
CELLTRAK-B |
R & D SYSTEMS, INC. |
|
K834483 |
12/06/1983 |
DIGI-X |
RADIATION MEASUREMENTS, INC. |
|
K834481 |
12/15/1983 |
DOPPLER PHANTOM FLOW CONTROL SYS |
RADIATION MEASUREMENTS, INC. |
|
K834607 |
12/16/1983 |
ELECTRONIC KVP CASSETTE |
RADIATION MEASUREMENTS, INC. |
|
K834482 |
12/15/1983 |
TISSUE MIMICKING ULTRASOUND PHANTOMS |
RADIATION MEASUREMENTS, INC. |
|
K834523 |
12/21/1983 |
MODEL M410D HEARING AID |
RADIOEAR CORP. |
|
K834479 |
12/20/1983 |
RELIABLE |
RELIABLE HEARING AIDE |
|
K834596 |
12/30/1983 |
BLOOD TUBING |
RENAL SYSTEMS, INC. |
|
K834510 |
12/21/1983 |
RENAFLO AVF SET FOR HEMODIALYSIS |
RENAL SYSTEMS, INC. |
|
K834151 |
12/01/1983 |
CONCHATHERM LHF HUMIDIFIER HEATER |
RESPIRATORY CARE, INC. |
|
K834522 |
12/21/1983 |
VENTI-VOICE NASAL CATHETER |
RESPIRATORY SUPPORT PRODUCTS, INC. |
|
K834502 |
12/21/1983 |
CK-NAC REAGENT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
|
K834430 |
12/16/1983 |
OMNI INFANT PHOTOTHERAPY UNIT |
ROCKY MOUNTAIN MEDICAL CORP. |
|
K834435 |
12/19/1983 |
CROWN & BRIDGE RESIN |
ROHM AND HAAS CO. |
|
K834250 |
12/07/1983 |
RESCUE MASK |
RONDEX PRODUCTS, INC. |
|
K834512 |
12/21/1983 |
SANDMILL RMS |
SANDHILL SCIENTIFIC, INC. |
|
K834247 |
12/07/1983 |
MATERIAL TOOTHSADE RESIN |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
K834396 |
12/14/1983 |
DIRECT IRON REAGENT SET |
SERAGEN DIAGNOSTICS, INC. |
|
K834328 |
12/09/1983 |
DAT TEST FOR CHAGAS' DISEASE |
SERO-IMMUNO DIAGNOSTICS, INC. |
|
K834428 |
12/15/1983 |
ALDOSTERONE RADIOIMMUNOASSAY TEST KIT |
SERONO LABORATORIES, INC. |
|
K834562 |
12/28/1983 |
ENTERNAL FEEDING TUBE |
SHERIDAN CATHETER CORP. |
|
K834463 |
12/20/1983 |
LARYNGOTRACHEAL TOPICAL ANES. APPLI |
SHERIDAN CATHETER CORP. |
|
K834249 |
12/07/1983 |
MONOJECT SOFT TISSUE BIOPSY NEEDLE |
SHERWOOD MEDICAL CO. |
|
K834497 |
12/20/1983 |
SHOFU PORCELAIN STAIN |
SHOFU DENTAL CORP. |
|
K834349 |
12/13/1983 |
ANTI-NATIVE DNA ANTIBODY |
SIGMA CHEMICAL CO. |
|
K834597 |
12/30/1983 |
ALPHA MASS STORAGE CARDULE 1895 |
SPACELABS, INC. |
|
K834460 |
12/19/1983 |
MODEL 1888 ALPHA COS/RESPIRATION CAR |
SPACELABS, INC. |
|
K834494 |
12/14/1983 |
SPECTRUM X-RAY CORP |
SPECTRUM X-RAY CORP. |
|
K834229 |
12/06/1983 |
BONE PLUGGING TOOL |
STANDARD SURGICAL |
|
K834237 |
12/06/1983 |
GRADUATED GUIDE WIRE BOWL 8" |
STERILE DESIGN, INC. |
|
K834239 |
12/06/1983 |
SDI C-FLEX STERILE LIGHT HANDLE |
STERILE DESIGN, INC. |
|
K834367 |
12/09/1983 |
SUTURE REMOVAL WOUND CLOSURE-INSTRU- |
STERLING MULTI-PRODUCTS, INC. |
|
K834514 |
12/21/1983 |
FASCIA CUTTER |
STRYKER CORP. |
|
K834515 |
12/21/1983 |
FIXATION STAPLE KIT - DLIDE HAMMER |
STRYKER CORP. |
|
K834513 |
12/21/1983 |
FIXATION STAPLES |
STRYKER CORP. |
|
K834434 |
12/19/1983 |
MACH I ELECTROSURGERY HAND CONTROL |
SURGICAL PRODUCTS CORP. |
|
K834347 |
12/13/1983 |
FLEXI-FLATE PENILE IMPLANT |
SURGITEK |
|
K834458 |
12/19/1983 |
EMIT D.A.U. URINE CANNABINOID ASSAY |
SYVA CO. |
|
K834457 |
12/19/1983 |
EMIT D.A.U. URINE CANNABINOID CALIBRA |
SYVA CO. |
|
K834216 |
12/05/1983 |
EMIT QST PHENOBARBITAL ASSAY |
SYVA CO. |
|
K834406 |
12/14/1983 |
EMIT QST PHENYTOIN ASSAY |
SYVA CO. |
|
K834550 |
12/27/1983 |
EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT |
SYVA CO. |
|
K834549 |
12/27/1983 |
EMIT ST. URINE COCAINE METABOLITE |
SYVA CO. |
|
K834218 |
12/08/1983 |
DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - |
TAGO, INC. |
|
K834442 |
12/16/1983 |
LED STIMULATOR LS-05 |
TECA, INC. |
|
K834411 |
12/15/1983 |
TECHMEDICA-HEWSON SHOULDER CLEAT |
TECHMEDICA, INC. |
|
K834486 |
12/07/1983 |
TECHNICARE 280 |
TECHNICARE CORP. |
|
K834149 |
12/01/1983 |
AUTOGROUPER 16C SYS AUTOMATED REAG |
TECHNICON INSTRUMENTS CORP. |
|
K834599 |
12/30/1983 |
AUTOTECHNICON V TISSUE PROCESS SYS |
TECHNICON INSTRUMENTS CORP. |
|
K834539 |
12/14/1983 |
AXIPAC II |
TEKNAR, INC. |
|
K834533 |
12/22/1983 |
ELECTRODE LEAD CONSTRUCTION |
TELECTRONICS, INC. |
|
K834265 |
12/08/1983 |
TRACH MATE |
TEMPE BIOMEDICAL, INC. |
|
K834215 |
12/05/1983 |
MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM |
TH CHARTERS, INC. |
|
K834538 |
12/12/1983 |
LAS-2 ALIGNMENT SYSTEM |
THERADOS, INC. |
|
K834201 |
12/05/1983 |
TCT-1 TREATMENT COUCH |
THERADOS, INC. |
|
K834451 |
12/19/1983 |
COAXIAL BALLOON GASTROESOPHAGEAL DILA |
THOMAS J. FOGARTY, M.D. |
|
K834519 |
12/21/1983 |
CALMTONE |
THOUGHT TECHNOLOGY LTD. |
|
K834274 |
12/08/1983 |
CRITERION I |
TIMETER INSTRUMENT CORP. |
|
K834289 |
12/08/1983 |
CONTINU-FLO SOLUTION ADMIN. 2C9102 |
TRAVENOL LABORATORIES, S.A. |
|
K834154 |
12/02/1983 |
FLO-GARD 8000 COMPUTER CONTROL INFUSI |
TRAVENOL LABORATORIES, S.A. |
|
K834224 |
12/06/1983 |
VACUUM REGULATOR 0-2000 MMHG VR-1000 |
TRIMETER INSTRUMENT CORP. |
|
K834591 |
12/29/1983 |
STOPEX-CONDOMS- |
TROPEX WORLDWIDE, INC. |
|
K834261 |
12/08/1983 |
PLASTIC OPTICAL LENS M-110 |
U-MOLDE SYSTEMS, INC. |
|
K834525 |
12/21/1983 |
ANGIOSCAN FLO MAD SPECTRUM ANALYZER |
UNIGON INDUSTRIES, INC. |
|
K834501 |
12/21/1983 |
ANGIOSCANE SPECTRUM ANALYZER |
UNIGON INDUSTRIES, INC. |
|
K834436 |
12/19/1983 |
CHEMONUCLEOLYSIS NEEDLE |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
|
K834358 |
12/13/1983 |
PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA |
VAS-CATH OF CANADA LTD. |
|
K834232 |
12/06/1983 |
VAS-CATH DSA CATHETER/TRAY |
VAS-CATH OF CANADA LTD. |
|
K834476 |
12/20/1983 |
NEPHROSTOMY/BILIARY DRAINAGE BAG |
VERTEX MEDICAL CORP. |
|
K834545 |
12/27/1983 |
POCKETIP 4414 |
VIPONT LABORATORIES, INC. |
|
K834448 |
12/16/1983 |
URINARY DRAINAGE CONTAINER |
VITALMETRICS, INC. |
|
K834269 |
12/08/1983 |
AMS GRAM-NEGATIVE IDENT. CARD |
VITEK SYSTEMS, INC. |
|
K834389 |
12/14/1983 |
AMS GRAM-POSITIVE IDENT. CARD |
VITEK SYSTEMS, INC. |
|
K834527 |
12/21/1983 |
THROMBO PLUS |
W. SARSTEDT, INC. |
|
K834532 |
12/21/1983 |
STERILE WET DRESSING PACK |
W.G. WHITNEY CORP. |
|
K834536 |
12/22/1983 |
CRYSTALCONE FACE MASK-MED-W/HOOKRING |
WARNE SURGICAL PRODUCTS, LTD. |
|
K834454 |
12/19/1983 |
PAEDIATRIC FACE MASK 1-3 W/WO RING |
WARNE SURGICAL PRODUCTS, LTD. |
|
K834408 |
12/14/1983 |
TX-2 THERMAL DILUTION CARDIAC OUTPUT |
WATERS INSTRUMENTS, INC. |
|
K834602 |
12/30/1983 |
SWITCHING UNIT ELECTRODE CATHETER |
WEBSTER LABORATORIES, INC. |
|
K834208 |
12/05/1983 |
COLLOID OSMOMETER 4400 |
WESCOR, INC. |
|
K834214 |
12/05/1983 |
WESCOR 5500 VAPOR PRESSURE OSMOMETER |
WESCOR, INC. |
|
K834359 |
12/13/1983 |
ABSORBENT INCONTINENT PADS & BRIEFS |
WEYERHAEUSER CO. |
|
K834246 |
12/07/1983 |
PROGESTERONE TEST SET 125I 17-OH |
WIEN LABORATORIES, INC. |
|
K834498 |
12/20/1983 |
TRAIL CHAIR |
WINCHESTER INDUSTRIES, INC. |
|
K834385 |
12/14/1983 |
YD STRIP GLUCOSE U19 |
YD PHARMACEUTICAL CORP. |
|
K834386 |
12/14/1983 |
YD STRIP GP U20 |
YD PHARMACEUTICAL CORP. |
|
K834387 |
12/14/1983 |
YD STRIP GPH U21 |
YD PHARMACEUTICAL CORP. |
|
K834432 |
12/16/1983 |
ANTHRO-MODULAR TOTAL KNEE |
ZIMMER, INC. |
|
K834298 |
12/08/1983 |
UNICONDYLAR FIBER METAL KNEE |
ZIMMER, INC. |
|