FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K780616 |
04/19/1978 |
HYDRON BURN DISPOSABLE DISPENSER SET |
ABBOTT LABORATORIES |
|
K780606 |
04/19/1978 |
BANDAGE |
ABCO DEALERS, INC. |
|
K780603 |
04/21/1978 |
COLD PACK |
ABCO DEALERS, INC. |
|
K780600 |
04/19/1978 |
IRRIGATION TRAY |
ABCO DEALERS, INC. |
|
K780595 |
04/19/1978 |
MINI-IRRIGATION TRAY |
ABCO DEALERS, INC. |
|
K780604 |
04/19/1978 |
SHAVE PREP |
ABCO DEALERS, INC. |
|
K780612 |
04/19/1978 |
STOCKINETTE, STERILE |
ABCO DEALERS, INC. |
|
K780596 |
04/19/1978 |
STOPCOCK |
ABCO DEALERS, INC. |
|
K780602 |
04/19/1978 |
SYRINGE (IRRIGATION) |
ABCO DEALERS, INC. |
|
K780599 |
04/19/1978 |
SYRINGE, EAR & ULCER |
ABCO DEALERS, INC. |
|
K780591 |
04/19/1978 |
THERMOMETER KIT |
ABCO DEALERS, INC. |
|
K771614 |
04/12/1978 |
AUTO. WELL TYPE GAMMA COUNTERS |
ACTUS, INC. |
|
K771612 |
04/10/1978 |
WELL TYPE GAMMA COUNTER |
ACTUS, INC. |
|
K771613 |
04/10/1978 |
WELL TYPE GAMMA COUNTER |
ACTUS, INC. |
|
K780472 |
04/19/1978 |
INFANT INCUBATOR |
AIR-SHIELDS, INC. |
|
K780503 |
04/10/1978 |
INFUSION PUMP |
AIR-SHIELDS, INC. |
|
K780547 |
04/10/1978 |
STERILE ORTHOPEDIC STOCKINETTE |
ALBA-WALDENSIAN, INC. |
|
K780570 |
04/19/1978 |
TUBULAR DRESSING RETAINER |
ALBA-WALDENSIAN, INC. |
|
K780492 |
04/28/1978 |
GAMMA STIK 125I T3 UPTAKE KIT |
ALPHA GAMMA LABORATORY |
|
K780488 |
04/12/1978 |
INSTRUMENT AND ACCESSORY KIT |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K780336 |
04/03/1978 |
URINE SAMPLE KIT |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K780443 |
04/24/1978 |
SGOT/AST REAGENT SYSTEM |
AMERICAN MONITOR CORP. |
|
K780343 |
04/18/1978 |
ARRHYTHMIA TREND ENHANCEMENT |
AMERICAN OPTICAL CORP. |
|
K780625 |
04/28/1978 |
UNISTAT OXIMETER |
AMERICAN OPTICAL CORP. |
|
K780516 |
04/28/1978 |
GENTAMICIN RIA KIT |
ANTIBODIES INC. |
|
K780358 |
04/28/1978 |
ACCES. ANALOG OUTPUT ADAPTOR MODEL 910 |
APPLIED MEDICAL RESEARCH |
|
K780259 |
04/18/1978 |
CATHETERIZATION TRAY & KIT |
ARGON MEDICAL CORP. |
|
K780532 |
04/21/1978 |
PERCUTANEOUS SHEATH INTRODUCER KIT |
ARROW INTL., INC. |
|
K780312 |
04/05/1978 |
AUTONOM |
AUTONOMIC EQUIPMENT SUPPLY CO, |
|
K780617 |
04/18/1978 |
EQUALIZER |
BALLERT ORTHOPEDIC CORP. |
|
K780530 |
04/28/1978 |
AUTOMATED PHYSIOLOGIC PROFILER |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K780097 |
04/24/1978 |
QUALITY CONTROL SYSTEM, SPECTRA |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K780556 |
04/24/1978 |
SPECT RIM (LISS) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K780477 |
04/13/1978 |
PHYSIOLOGICAL PRESSURE TRANSDUCER |
BELL & HOWELL INSTRUMENTS |
|
K780357 |
04/05/1978 |
TITANIUM MULLER TOTAL HIP |
BIOMET, INC. |
|
K780510 |
04/18/1978 |
NUCLEAR STETHOSCOPE |
BIOS, INC. |
|
K780439 |
04/18/1978 |
PRECIMAT GLYCEROL |
BOEHRINGER MANNHEIM CORP. |
|
K780563 |
04/18/1978 |
SINGLE VIAL LACTATE |
BOEHRINGER MANNHEIM CORP. |
|
K780475 |
04/24/1978 |
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT |
BURROUGHS WELLCOME CO. |
|
K780409 |
04/27/1978 |
COLOPLAST-DURASEAL OSTOMY APPLIANCE |
C.R. BARD, INC. |
|
K780347 |
04/12/1978 |
RIA SYS. FOR HUMAN GROWTH HORMONE |
CALBIOCHEM-BEHRING CORP. |
|
K780367 |
04/28/1978 |
RIA SYS. FOR HUMAN LUTEINIZING HORMONE |
CALBIOCHEM-BEHRING CORP. |
|
K780666 |
04/27/1978 |
DAYSTAR SELECTRA & SELECTRA/ORBITER |
CASTLE CO. |
|
K780337 |
04/12/1978 |
THERMOLYSIS GENERATOR |
CLARE, INC. |
|
K780366 |
04/07/1978 |
SOLID-OX EMERGENCY OXYGEN |
CLEANWELD PRODUCTS, INC. |
|
K780498 |
04/05/1978 |
CBR-DIGOXIN ANTISERUM |
CLINICAL BIORESEARCH |
|
K780387 |
04/12/1978 |
VABRA ABORTION UNIT |
COOPER LABORATORIES |
|
K780401 |
04/24/1978 |
THYRO-ZYME-T4 ASSAY KIT |
COULTER ELECTRONICS, INC. |
|
K780496 |
04/18/1978 |
TRAVELAIR AND STATIONAIR |
CRYOMED CORP. |
|
K780546 |
04/10/1978 |
BEHIND-THE-EAR MASKING AMPLIFIER,735S |
DANAVOX, INC. |
|
K780485 |
04/05/1978 |
PREBYPASS FILTER |
DELTA MEDICAL INDUSTRIES |
|
K780518 |
04/28/1978 |
ULTRANOVAR, DENTAL U.V. CURING LAMP |
DEMETRON RESEARCH CORP. |
|
K780469 |
04/10/1978 |
PANORAMIC X-RAY, DENTAL |
DEN-TAL-EZ MFG CO., INC. |
|
K780494 |
04/10/1978 |
AMIKACIN |
DIAGNOSTIC PRODUCTS CORP. |
|
K780495 |
04/10/1978 |
DIGITOXIN |
DIAGNOSTIC PRODUCTS CORP. |
|
K780470 |
04/27/1978 |
H.P. MEDICAL GRADE SILICONE TUBING |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
|
K780454 |
04/21/1978 |
ACTIVE-LIFE |
E. R. SQUIBB & SONS, INC. |
|
K780511 |
04/21/1978 |
SNAP-FIT |
E. R. SQUIBB & SONS, INC. |
|
K780295 |
04/05/1978 |
CALIBRATORS, CARBON DIOXIDE |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K772387 |
04/05/1978 |
LEAD HAND |
EDWARD WECK, INC. |
|
K780493 |
04/10/1978 |
ELECATH PLASTIC JACKETED GUIDEWIRE |
ELECTRO-CATHETER CORP. |
|
K780359 |
04/04/1978 |
OXYGEN REGULATOR/FLOWMETER |
ERIE MFG., CO. |
|
K780567 |
04/28/1978 |
AORTIC PUMP |
ETHICON, INC. |
|
K780244 |
04/13/1978 |
CATHETERS, ARTERIAL EMBOLECTOMY |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K780566 |
04/21/1978 |
HEALTH SEAT SYSTEM |
G & W APPLIED SCIENCE LABORATORIES |
|
K780480 |
04/18/1978 |
CT/T INDEPENDENT DIAGNOSTIC CENTER |
GENERAL ELECTRIC CO. |
|
K780491 |
04/18/1978 |
DATA CAMERA |
GENERAL ELECTRIC CO. |
|
K780533 |
04/18/1978 |
PRE-REDUCED MEDIA |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K780425 |
04/28/1978 |
BIOPHYSICAL MONITORING SYSTEM |
GOULD, INC. |
|
K780137 |
04/28/1978 |
CLAMP, INCONTINENCE, BAUMRUCKER |
GREENWALD SURGICAL CO., INC. |
|
K780429 |
04/18/1978 |
TOURNEQUET, NON-PNEUMATIC |
HEMOX, INC. |
|
K780417 |
04/18/1978 |
ASEPTIC TRANSFER SET |
HEYER SCHULTE CORP. |
|
K780414 |
04/10/1978 |
OCTOPUS |
HITRON CORP. |
|
K780640 |
04/28/1978 |
DRY SILVER PROCESSOR MODEL 1226 |
HONEYWELL, INC. |
|
K780535 |
04/27/1978 |
HUMIDIFIER FILTER |
HUDSON OXYGEN THERAPY SALES CO. |
|
K780262 |
04/05/1978 |
DIRECT UREA NITROGEN TEST |
HYCEL, INC. |
|
K780526 |
04/28/1978 |
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM |
I M, INC. |
|
K780437 |
04/05/1978 |
PACEMAKER, MODEL 252, C-MOS |
INTERMEDICS, INC. |
|
K780175 |
04/21/1978 |
RATE PROGRAMMER MODEL 520 |
INTERMEDICS, INC. |
|
K780321 |
04/04/1978 |
PREGNANCY TEST KIT, OVER-THE-COUNTER |
INTL. DIAGNOSTIC, INC. |
|
K780416 |
04/21/1978 |
PANTRIDGE MK III DEFIBRILLATOR/MONITOR |
IPCO CORP. |
|
K780386 |
04/13/1978 |
K-Y LUBRICATING JELLY |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K780251 |
04/06/1978 |
NEPHELOMETER |
KALLESTAD LABORATORIES, INC. |
|
K780560 |
04/21/1978 |
DENTAL AMALGAMATOR |
L.D. CAULK CO. |
|
K780575 |
04/18/1978 |
LASCHAL SCISSOR |
LASCHAL INSTRUMENT CORP. |
|
K780538 |
04/19/1978 |
AUDIO MONITOR-MODEL 8309 |
LIFE-TECH INSTRUMENTS, INC. |
|
K780540 |
04/21/1978 |
ELECTRIC RESPONSE AUDIOMETER |
LIFE-TECH INSTRUMENTS, INC. |
|
K780344 |
04/12/1978 |
GAMMA COUNTER |
LKB INSTRUMENTS, INC. |
|
K780351 |
04/24/1978 |
NORMAL UNASSAYED CONTROL SERA |
MACOMB CHEMICAL CO. |
|
K780353 |
04/05/1978 |
DRI-LYTE |
MALLINCKRODT CRITICAL CARE |
|
K780440 |
04/10/1978 |
CHAMBER, AEROBIC |
MARION LABORATORIES, INC. |
|
K780489 |
04/12/1978 |
SPINE BOARD |
MARULLO, BALDWIN, FRIEDEN, GATEWOOD, |
|
K780370 |
04/10/1978 |
STAND UP TOILET |
MEDICAL SPECIALTY PRODUCTS, INC. |
|
K780371 |
04/10/1978 |
TILT TYPE AC POWERED HOSPITAL BED |
MEDICAL SPECIALTY PRODUCTS, INC. |
|
K780646 |
04/28/1978 |
AIR-PWOERED COLDRILL |
MEDISHIELD, INC. |
|
K780444 |
04/19/1978 |
NERVTRON-RX |
MEDIX CORP. |
|
K780302 |
04/21/1978 |
BLOOD FLOWMETER SYSTEM |
MEDTRONIC VASCULAR |
|
K780114 |
04/19/1978 |
IMMUNOZYME E. HISTOLYTICA ANTIGENS |
MILLIPORE CORP. |
|
K780551 |
04/19/1978 |
I.V. ADMINISTRATION SET WITH MINI-SPIKE |
NATIONAL PATENT DEVELOPMENT CORP. |
|
K780549 |
04/19/1978 |
NON-STICK PADS |
NATIONAL PATENT DEVELOPMENT CORP. |
|
K780550 |
04/19/1978 |
STERILE AIR SYRINGE |
NATIONAL PATENT DEVELOPMENT CORP. |
|
K780405 |
04/05/1978 |
INFANT ELECTROSURGICAL GROUNDING PAD |
NEW DIMENSIONS IN MEDICINE, INC. |
|
K780490 |
04/10/1978 |
NEIA-FERRITIN ENZYMEIMMUNOASSAY |
NEW ENGLAND IMMUNOLOGY ASSOC. |
|
K780279 |
04/10/1978 |
ICE-PAK, PDI |
NICE-PAK PRODUCTS, INC. |
|
K772116 |
04/28/1978 |
AMINOGLYCOSIDE TEST SYSTEM |
NICHOLS INSTITUTE DIAGNOSTICS |
|
K780415 |
04/10/1978 |
VIVONEX DELIVERY SYSTEM |
NORWICH PHARMACAL CO. |
|
K780502 |
04/10/1978 |
NOVA AIR FLOATATION SYSTEM |
NOVA HEALTH SYSTEMS, INC. |
|
K780644 |
04/28/1978 |
RADIOASSAY FOR TOTAL SERUM THYROXINE |
NUCLEAR DIAGNOSTICS, INC. |
|
K780486 |
04/28/1978 |
STIKSEP-T3 KIT |
NUCLEAR DIAGNOSTICS, INC. |
|
K780308 |
04/12/1978 |
OREIA-T4 |
ORGANON, INC. |
|
K780654 |
04/28/1978 |
HEARING AID, EARETTE |
OTICON CORP. |
|
K780413 |
04/24/1978 |
LOW IIONIC STRENGTH SOLUTION |
PFIZER, INC. |
|
K780331 |
04/06/1978 |
CHOLESTEROL RAPID SLAT KIT HDL |
PIERCE CHEMICAL CO. |
|
K780168 |
04/18/1978 |
PARAMEDIC O2 KIT |
POHLMANN RESCUE PRODUCTS, INC. |
|
K780528 |
04/19/1978 |
PREMIER CARVERS, STYLE #21C & 21D |
PREMIER DENTAL PRODUCTS CO. |
|
K780422 |
04/04/1978 |
PINWHEEL |
PROJECTS IN HEALTH |
|
K780426 |
04/27/1978 |
BODY WARMER |
Q-MATIC CORP. |
|
K780643 |
04/27/1978 |
SHADOW-CATHS |
QUINTON, INC. |
|
K780562 |
04/27/1978 |
AQUAPAK PREFILLED HUMIDIFIER |
RESPIRATORY CARE, INC. |
|
K780580 |
04/27/1978 |
TEMPERATURE INDICATOR |
RESPIRATORY CARE, INC. |
|
K780299 |
04/27/1978 |
TOTAL KNEE SYSTEM |
RICHARD'S MEDICAL EQUIP., INC. |
|
K780678 |
04/28/1978 |
IMPRESSION TRAY |
ROCKY MOUNTAIN ORTHODONTICS, INC. |
|
K780255 |
04/18/1978 |
NEEDLE DRIVER |
SCANLAN INTL., INC. |
|
K780311 |
04/05/1978 |
DIAGNOSTIC KIT, CPK |
SCLAVO, INC. |
|
K780188 |
04/10/1978 |
INFANT VENTILATOR MODEL 100 |
SECHRIST INDUSTRIES, INC. |
|
K780261 |
04/18/1978 |
COVERSLIPPER |
SHANDON, INC. |
|
K780220 |
04/10/1978 |
HOOD, INFANT OXYGEN |
SHILEY, INC. |
|
K780355 |
04/18/1978 |
ATROXIN |
SIGMA CHEMICAL CO. |
|
K780209 |
04/10/1978 |
DILUTION SPIKE |
STERLING DRUG, INC. |
|
K780483 |
04/28/1978 |
FIBER OPTIC HANDPIECE |
SYNTEX CORP. |
|
K780380 |
04/12/1978 |
ANALYZER, FAST, CENTRIFUGAL, GEMSAEC |
SYVA CO. |
|
K780461 |
04/12/1978 |
ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 |
SYVA CO. |
|
K780467 |
04/24/1978 |
EMIT ANTIEPILEPTIC DRUG CALIBRATORS |
SYVA CO. |
|
K780466 |
04/24/1978 |
EMIT CARBAMAZEPINE ASSAY |
SYVA CO. |
|
K780441 |
04/12/1978 |
THEOPHYLLINE ASSAY TO THE CENTRIFICHEM |
SYVA CO. |
|
K780442 |
04/12/1978 |
THEOPHYLLINE ASSAY TO THE GEMSAEC |
SYVA CO. |
|
K780411 |
04/13/1978 |
TAYLOR CATHETER HOLDER |
TAYLOR CATHETER HOLDER MFG. |
|
K780448 |
04/19/1978 |
TRANSPORTABLE OXYGEN PURITY ANALYZER |
TAYLOR INSTRUMENT ANALYTICS CO. |
|
K780544 |
04/24/1978 |
DISC-PAK ROTATOR |
TECHHNILAB INSTRUMENTS, INC. |
|
K780373 |
04/28/1978 |
STAC SYSTEM |
TECHNICON INSTRUMENTS CORP. |
|
K780641 |
04/21/1978 |
DENTAL ROTARY CARBIDE BURS 76EJL |
TELEDYNE DENSCO |
|
K780418 |
04/10/1978 |
BURN DRESSING PAD |
THE OWENBY CO. |
|
K780129 |
04/05/1978 |
ATOMIZER, FURNACE, GRAPHITE |
THE PERKIN-ELMER CORP. |
|
K780342 |
04/10/1978 |
SPECTROPHOTOMETERS |
THE PERKIN-ELMER CORP. |
|
K780394 |
04/10/1978 |
GAUZE FLUFF |
THE TORRENT CORP. |
|
K780318 |
04/12/1978 |
MODULAR SCANNING DENSITOMETER SYS. |
TRANSIDYNE GENERAL CORP. |
|
K780407 |
04/10/1978 |
2C7125 BLOW BOTTLE |
TRAVENOL LABORATORIES, S.A. |
|
K780406 |
04/12/1978 |
2C7153 NEBULIZER CAP |
TRAVENOL LABORATORIES, S.A. |
|
K780517 |
04/13/1978 |
CARDIOTOMY RESERVOIR |
TRAVENOL LABORATORIES, S.A. |
|
K780481 |
04/10/1978 |
I.V. LEVER CLAMP |
TRAVENOL LABORATORIES, S.A. |
|
K780456 |
04/12/1978 |
NEBULIZER HEATER |
TRAVENOL LABORATORIES, S.A. |
|
K780119 |
04/03/1978 |
NEBULIZER, DISP, 2D0815 |
TRAVENOL LABORATORIES, S.A. |
|
K780223 |
04/10/1978 |
PARENTERAL INFUSION CONTROLLER |
TRAVENOL LABORATORIES, S.A. |
|
K780531 |
04/13/1978 |
MILLER TABLE |
VICTOR JOHN MANLEY |
|
K780215 |
04/10/1978 |
EYESCOPE |
VISUAL METHODS, INC. |
|
K770534 |
04/21/1978 |
THERAPEUTIC APPARATUS, DIERKER TYPE |
WELL BEING ENT. |
|
K780131 |
04/10/1978 |
THERMOMETER, DIGITAL, NTM-100 |
WILTON WEBSTER LABORATORIES |
|
K780389 |
04/19/1978 |
HDL REAGENT SET FOR LIPOPROTEINS |
WORTHINGTON BIOCHEMICAL CORP. |
|