1978
1,975 FDA 510(k) clearances · Clearance year
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| Record | Firm | Date |
|---|---|---|
| COVERSLIPPER (K780261) | Shandon, Inc. | 1978-04-18 |
| NEEDLE DRIVER (K780255) | Scanlan Intl., Inc. | 1978-04-18 |
| PRE-REDUCED MEDIA (K780533) | Gibco Laboratories Life Technologies, Inc. | 1978-04-18 |
| EQUALIZER (K780617) | Ballert Orthopedic Corp. | 1978-04-18 |
| DATA CAMERA (K780491) | General Electric Co. | 1978-04-18 |
| LASCHAL SCISSOR (K780575) | Laschal Instrument Corp. | 1978-04-18 |
| CARDIOTOMY RESERVOIR (K780517) | Travenol Laboratories, S.A. | 1978-04-13 |
| MILLER TABLE (K780531) | Victor John Manley | 1978-04-13 |
| PHYSIOLOGICAL PRESSURE TRANSDUCER (K780477) | Bell & Howell Instruments | 1978-04-13 |
| TAYLOR CATHETER HOLDER (K780411) | Taylor Catheter Holder Mfg. | 1978-04-13 |
| CATHETERS, ARTERIAL EMBOLECTOMY (K780244) | Extracorporeal Medical Specialities, Inc. | 1978-04-13 |
| K-Y LUBRICATING JELLY (K780386) | Johnson & Johnson Professionals, Inc. | 1978-04-13 |
| THEOPHYLLINE ASSAY TO THE GEMSAEC (K780442) | Syva Co. | 1978-04-12 |
| AUTO. WELL TYPE GAMMA COUNTERS (K771614) | Actus, Inc. | 1978-04-12 |
| ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 (K780461) | Syva Co. | 1978-04-12 |
| THEOPHYLLINE ASSAY TO THE CENTRIFICHEM (K780441) | Syva Co. | 1978-04-12 |
| GAMMA COUNTER (K780344) | Lkb Instruments, Inc. | 1978-04-12 |
| INSTRUMENT AND ACCESSORY KIT (K780488) | American Hospital Supply Corp. | 1978-04-12 |
| OREIA-T4 (K780308) | Organon, Inc. | 1978-04-12 |
| MODULAR SCANNING DENSITOMETER SYS. (K780318) | Transidyne General Corp. | 1978-04-12 |
| VABRA ABORTION UNIT (K780387) | Cooper Laboratories | 1978-04-12 |
| 2C7153 NEBULIZER CAP (K780406) | Travenol Laboratories, S.A. | 1978-04-12 |
| SPINE BOARD (K780489) | Marullo, Baldwin, Frieden, Gatewood, | 1978-04-12 |
| RIA SYS. FOR HUMAN GROWTH HORMONE (K780347) | Calbiochem-Behring Corp. | 1978-04-12 |
| THERMOLYSIS GENERATOR (K780337) | Clare, Inc. | 1978-04-12 |
| NEBULIZER HEATER (K780456) | Travenol Laboratories, S.A. | 1978-04-12 |
| ANALYZER, FAST, CENTRIFUGAL, GEMSAEC (K780380) | Syva Co. | 1978-04-12 |
| ELECATH PLASTIC JACKETED GUIDEWIRE (K780493) | Electro-Catheter Corp. | 1978-04-10 |
| STAND UP TOILET (K780370) | Medical Specialty Products, Inc. | 1978-04-10 |
| BURN DRESSING PAD (K780418) | The Owenby Co. | 1978-04-10 |
| WELL TYPE GAMMA COUNTER (K771612) | Actus, Inc. | 1978-04-10 |
| SPECTROPHOTOMETERS (K780342) | The Perkin-Elmer Corp. | 1978-04-10 |
| WELL TYPE GAMMA COUNTER (K771613) | Actus, Inc. | 1978-04-10 |
| AMIKACIN (K780494) | Diagnostic Products Corp. | 1978-04-10 |
| 2C7125 BLOW BOTTLE (K780407) | Travenol Laboratories, S.A. | 1978-04-10 |
| DIGITOXIN (K780495) | Diagnostic Products Corp. | 1978-04-10 |
| INFUSION PUMP (K780503) | Air-Shields, Inc. | 1978-04-10 |
| VIVONEX DELIVERY SYSTEM (K780415) | Norwich Pharmacal Co. | 1978-04-10 |
| STERILE ORTHOPEDIC STOCKINETTE (K780547) | Alba-Waldensian, Inc. | 1978-04-10 |
| INFANT VENTILATOR MODEL 100 (K780188) | Sechrist Industries, Inc. | 1978-04-10 |
| CHAMBER, AEROBIC (K780440) | Marion Laboratories, Inc. | 1978-04-10 |
| OCTOPUS (K780414) | Hitron Corp. | 1978-04-10 |
| NOVA AIR FLOATATION SYSTEM (K780502) | Nova Health Systems, Inc. | 1978-04-10 |
| NEIA-FERRITIN ENZYMEIMMUNOASSAY (K780490) | New England Immunology Assoc. | 1978-04-10 |
| I.V. LEVER CLAMP (K780481) | Travenol Laboratories, S.A. | 1978-04-10 |
| THERMOMETER, DIGITAL, NTM-100 (K780131) | Wilton Webster Laboratories | 1978-04-10 |
| HOOD, INFANT OXYGEN (K780220) | Shiley, Inc. | 1978-04-10 |
| DILUTION SPIKE (K780209) | Sterling Drug, Inc. | 1978-04-10 |
| EYESCOPE (K780215) | Visual Methods, Inc. | 1978-04-10 |
| BEHIND-THE-EAR MASKING AMPLIFIER,735S (K780546) | Danavox, Inc. | 1978-04-10 |
| PARENTERAL INFUSION CONTROLLER (K780223) | Travenol Laboratories, S.A. | 1978-04-10 |
| GAUZE FLUFF (K780394) | The Torrent Corp. | 1978-04-10 |
| PANORAMIC X-RAY, DENTAL (K780469) | Den-Tal-Ez Mfg Co., Inc. | 1978-04-10 |
| ICE-PAK, PDI (K780279) | Nice-Pak Products, Inc. | 1978-04-10 |
| TILT TYPE AC POWERED HOSPITAL BED (K780371) | Medical Specialty Products, Inc. | 1978-04-10 |
| SOLID-OX EMERGENCY OXYGEN (K780366) | Cleanweld Products, Inc. | 1978-04-07 |
| NEPHELOMETER (K780251) | Kallestad Laboratories, Inc. | 1978-04-06 |
| CHOLESTEROL RAPID SLAT KIT HDL (K780331) | Pierce Chemical Co. | 1978-04-06 |
| DRI-LYTE (K780353) | Mallinckrodt Critical Care | 1978-04-05 |
| PREBYPASS FILTER (K780485) | Delta Medical Industries | 1978-04-05 |
| PACEMAKER, MODEL 252, C-MOS (K780437) | Intermedics, Inc. | 1978-04-05 |
| INFANT ELECTROSURGICAL GROUNDING PAD (K780405) | New Dimensions IN Medicine, Inc. | 1978-04-05 |
| ATOMIZER, FURNACE, GRAPHITE (K780129) | The Perkin-Elmer Corp. | 1978-04-05 |
| CBR-DIGOXIN ANTISERUM (K780498) | Clinical Bioresearch | 1978-04-05 |
| DIAGNOSTIC KIT, CPK (K780311) | Sclavo, Inc. | 1978-04-05 |
| LEAD HAND (K772387) | Edward Weck, Inc. | 1978-04-05 |
| TITANIUM MULLER TOTAL HIP (K780357) | Biomet, Inc. | 1978-04-05 |
| AUTONOM (K780312) | Autonomic Equipment Supply Co, | 1978-04-05 |
| CALIBRATORS, CARBON DIOXIDE (K780295) | E.I. Dupont DE Nemours & Co., Inc. | 1978-04-05 |
| DIRECT UREA NITROGEN TEST (K780262) | Hycel, Inc. | 1978-04-05 |
| PINWHEEL (K780422) | Projects IN Health | 1978-04-04 |
| PREGNANCY TEST KIT, OVER-THE-COUNTER (K780321) | Intl. Diagnostic, Inc. | 1978-04-04 |
| OXYGEN REGULATOR/FLOWMETER (K780359) | Erie Mfg., Co. | 1978-04-04 |
| URINE SAMPLE KIT (K780336) | American Hospital Supply Corp. | 1978-04-03 |
| NEBULIZER, DISP, 2D0815 (K780119) | Travenol Laboratories, S.A. | 1978-04-03 |
| IMAGER, BODY SECTION, RADIONUCLIDE (K780395) | Union Carbide Corp. | 1978-03-31 |
| DIALYZING FLUIDE DELIVERY SYSTEM (K780081) | Travenol Laboratories, S.A. | 1978-03-31 |
| CLEARTONE MODEL-1 & 2 HEARING AIDS (K780459) | Cleartone Custom Hearing Instruments | 1978-03-30 |
| SOLUBLE COLLAGEN (K780285) | General Diagnostics | 1978-03-30 |
| PLATELET ROTATOR (K780189) | Travenol Laboratories, S.A. | 1978-03-30 |
| TRACOR RA 410 AUDIOMETER (K780450) | Tracor Instruments, Inc. | 1978-03-30 |
| OXYGEN/NITROUS OXIDE OUTLET (K780365) | Spica, Inc. | 1978-03-30 |
| AUTO ISO-FILTER COLLECTION TUBE CAP (K780303) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-30 |
| AUDIOMETER CALIBRATOR MODEL RA 310 (K780474) | Tracor Instruments, Inc. | 1978-03-30 |
| ROCHE TSH RIA (K780428) | Hoffmann-La Roche, Inc. | 1978-03-30 |
| STIKSEP-T4 RIA KIT (K780423) | Nuclear Diagnostics, Inc. | 1978-03-30 |
| MANIFOLD KIT (K780364) | Spica, Inc. | 1978-03-30 |
| ADHESIVE, BRACKET AND CONDITIONER RESIN (K780334) | Rocky Mountain Orthodontics, Inc. | 1978-03-28 |
| I.V. START KIT (K780222) | Marion Laboratories, Inc. | 1978-03-28 |
| HDL CHOLESTEROL METHOD (K780256) | Helena Laboratories | 1978-03-28 |
| ECG MONITORING SYSTEM, (K780404) | Quinton, Inc. | 1978-03-28 |
| G WRAP (K780294) | Cel-Fibe | 1978-03-28 |
| REAGENT SYSTEM, ARIA II T3 UPTAKE (K780253) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-28 |
| REDI-DISC HEMOGLOBIN GEL TUBE KIT (K780163) | Miles Laboratories, Inc. | 1978-03-27 |
| I.V. START KIT (K780350) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-27 |
| SPECTROPHOTOMETER, FLUORESCENCE M.650-10 (K780242) | The Perkin-Elmer Corp. | 1978-03-27 |
| THROMBOPLASTIN DRIED (K780203) | Hyland Therapeutic Div., Travenol Laboratories | 1978-03-27 |
| DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 (K780162) | Cavitron Corp. | 1978-03-27 |
| CELL-CHEX (K780140) | Streck Laboratories, Inc. | 1978-03-27 |
| SUBCLAVIAN TRAY (K780419) | Concord Laboratories, Inc. | 1978-03-27 |
Track 1978 automatically
Every clearance here is in the API, with alerts when new ones post.