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32,815 FDA 510(k) clearances · Device class
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| Record | Firm | Date |
|---|---|---|
| GOAT ANTI-INFLUENZA ANTISERA ATEXAS (K780697) | Northeast Biomedical Labs., Inc. | 1978-05-03 |
| LELECTIVE KINETIC SYSTEM-60 (K780464) | Hycel, Inc. | 1978-05-03 |
| HEATING AIDS-MODEL C78A & C78B (K780669) | Circle Hearing Instruments, Inc. | 1978-05-03 |
| HEARING AID-MODEL 2010 (K780667) | Radioear Corp. | 1978-05-03 |
| AIR-PWOERED COLDRILL (K780646) | Medishield, Inc. | 1978-04-28 |
| CLAMP, INCONTINENCE, BAUMRUCKER (K780137) | Greenwald Surgical Co., Inc. | 1978-04-28 |
| IMPRESSION TRAY (K780678) | Rocky Mountain Orthodontics, Inc. | 1978-04-28 |
| DRY SILVER PROCESSOR MODEL 1226 (K780640) | Honeywell, Inc. | 1978-04-28 |
| AORTIC PUMP (K780567) | ETHICON, Inc. | 1978-04-28 |
| STAC SYSTEM (K780373) | Technicon Instruments Corp. | 1978-04-28 |
| HEARING AID, EARETTE (K780654) | Oticon Corp. | 1978-04-28 |
| RIA SYS. FOR HUMAN LUTEINIZING HORMONE (K780367) | Calbiochem-Behring Corp. | 1978-04-28 |
| FIBER OPTIC HANDPIECE (K780483) | Syntex Corp. | 1978-04-28 |
| BODY WARMER (K780426) | Q-Matic Corp. | 1978-04-27 |
| COLOPLAST-DURASEAL OSTOMY APPLIANCE (K780409) | C.R. Bard, Inc. | 1978-04-27 |
| NORMAL UNASSAYED CONTROL SERA (K780351) | Macomb Chemical Co. | 1978-04-24 |
| DISC-PAK ROTATOR (K780544) | Techhnilab Instruments, Inc. | 1978-04-24 |
| COLD PACK (K780603) | Abco Dealers, Inc. | 1978-04-21 |
| SNAP-FIT (K780511) | E. R. Squibb & Sons, Inc. | 1978-04-21 |
| DENTAL AMALGAMATOR (K780560) | L.D. Caulk Co. | 1978-04-21 |
| DENTAL ROTARY CARBIDE BURS 76EJL (K780641) | Teledyne Densco | 1978-04-21 |
| ACTIVE-LIFE (K780454) | E. R. Squibb & Sons, Inc. | 1978-04-21 |
| HYDRON BURN DISPOSABLE DISPENSER SET (K780616) | Abbott Laboratories | 1978-04-19 |
| HDL REAGENT SET FOR LIPOPROTEINS (K780389) | Worthington Biochemical Corp. | 1978-04-19 |
| NON-STICK PADS (K780549) | National Patent Development Corp. | 1978-04-19 |
| SHAVE PREP (K780604) | Abco Dealers, Inc. | 1978-04-19 |
| BANDAGE (K780606) | Abco Dealers, Inc. | 1978-04-19 |
| STOCKINETTE, STERILE (K780612) | Abco Dealers, Inc. | 1978-04-19 |
| PREMIER CARVERS, STYLE #21C & 21D (K780528) | Premier Dental Products Co. | 1978-04-19 |
| TUBULAR DRESSING RETAINER (K780570) | Alba-Waldensian, Inc. | 1978-04-19 |
| SYRINGE, EAR & ULCER (K780599) | Abco Dealers, Inc. | 1978-04-19 |
| TOURNEQUET, NON-PNEUMATIC (K780429) | Hemox, Inc. | 1978-04-18 |
| PRECIMAT GLYCEROL (K780439) | Boehringer Mannheim Corp. | 1978-04-18 |
| NUCLEAR STETHOSCOPE (K780510) | Bios, Inc. | 1978-04-18 |
| CATHETERIZATION TRAY & KIT (K780259) | Argon Medical Corp. | 1978-04-18 |
| 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 |
| MILLER TABLE (K780531) | Victor John Manley | 1978-04-13 |
| AUTO. WELL TYPE GAMMA COUNTERS (K771614) | Actus, Inc. | 1978-04-12 |
| GAMMA COUNTER (K780344) | Lkb Instruments, Inc. | 1978-04-12 |
| INSTRUMENT AND ACCESSORY KIT (K780488) | American Hospital Supply Corp. | 1978-04-12 |
| MODULAR SCANNING DENSITOMETER SYS. (K780318) | Transidyne General Corp. | 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 |
| 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 |
| 2C7125 BLOW BOTTLE (K780407) | Travenol Laboratories, S.A. | 1978-04-10 |
| DIGITOXIN (K780495) | Diagnostic Products Corp. | 1978-04-10 |
| STERILE ORTHOPEDIC STOCKINETTE (K780547) | Alba-Waldensian, Inc. | 1978-04-10 |
| CHAMBER, AEROBIC (K780440) | Marion Laboratories, Inc. | 1978-04-10 |
| OCTOPUS (K780414) | Hitron Corp. | 1978-04-10 |
| HOOD, INFANT OXYGEN (K780220) | Shiley, Inc. | 1978-04-10 |
| GAUZE FLUFF (K780394) | The Torrent Corp. | 1978-04-10 |
| ICE-PAK, PDI (K780279) | Nice-Pak Products, Inc. | 1978-04-10 |
| NEPHELOMETER (K780251) | Kallestad Laboratories, Inc. | 1978-04-06 |
| CHOLESTEROL RAPID SLAT KIT HDL (K780331) | Pierce Chemical Co. | 1978-04-06 |
| ATOMIZER, FURNACE, GRAPHITE (K780129) | The Perkin-Elmer Corp. | 1978-04-05 |
| AUTONOM (K780312) | Autonomic Equipment Supply Co, | 1978-04-05 |
| PINWHEEL (K780422) | Projects IN Health | 1978-04-04 |
| OXYGEN REGULATOR/FLOWMETER (K780359) | Erie Mfg., Co. | 1978-04-04 |
| URINE SAMPLE KIT (K780336) | American Hospital Supply Corp. | 1978-04-03 |
| IMAGER, BODY SECTION, RADIONUCLIDE (K780395) | Union Carbide Corp. | 1978-03-31 |
| CLEARTONE MODEL-1 & 2 HEARING AIDS (K780459) | Cleartone Custom Hearing Instruments | 1978-03-30 |
| PLATELET ROTATOR (K780189) | Travenol Laboratories, S.A. | 1978-03-30 |
| OXYGEN/NITROUS OXIDE OUTLET (K780365) | Spica, Inc. | 1978-03-30 |
| AUDIOMETER CALIBRATOR MODEL RA 310 (K780474) | Tracor Instruments, Inc. | 1978-03-30 |
| MANIFOLD KIT (K780364) | Spica, Inc. | 1978-03-30 |
| HDL CHOLESTEROL METHOD (K780256) | Helena Laboratories | 1978-03-28 |
| SPECTROPHOTOMETER, FLUORESCENCE M.650-10 (K780242) | The Perkin-Elmer Corp. | 1978-03-27 |
| SUBCLAVIAN TRAY (K780419) | Concord Laboratories, Inc. | 1978-03-27 |
| CELL (K780305) | Dynatech Laboratories, Inc. | 1978-03-27 |
| DEN-Z-ORB (K780400) | Nice-Pak Products, Inc. | 1978-03-27 |
| RECORDER, RE-100P HOT STYLUS STRIP CHART (K780245) | Waters Assoc., Inc. | 1978-03-27 |
| SPECTROFLUOROMETER SF-330 (K780362) | Varian Assoc., Inc. | 1978-03-22 |
| COUNTER, RADIOASSAY, AUTO., MICROMEDIC (K780383) | Micromedic Systems | 1978-03-22 |
| MICRONET LIGHT DRESSING SPONGE (K780408) | Kendall Research Center | 1978-03-22 |
| SPECTROPHOTOMETER, ABSORPTION, ATOMIC (K780390) | Varian Assoc., Inc. | 1978-03-22 |
| MIF PROCEDURE KIT (K780346) | Marion Laboratories, Inc. | 1978-03-22 |
| ANALYZER, 100, BICHROMATIC, ABBOTT (K780388) | Syva Co. | 1978-03-22 |
| ORTHOPEDIC FORCEPS (K780397) | Orthopedic Equipment Co., Inc. | 1978-03-22 |
| PHONIC EAR (K780363) | Hc Electronics | 1978-03-21 |
| INSERTER, PLUG, BONE, LIDGE (K780283) | Depuy, Inc. | 1978-03-17 |
| NEEDLEHOLDER, MICROVASULAR 5 1/2 (K780154) | Edward Weck, Inc. | 1978-03-17 |
| INSTRUMENT CLEANING BRUSH (K780399) | Ransom and Randolph | 1978-03-17 |
| URINE SCREENING KITS (K780021) | Diagnostic Culture System | 1978-03-17 |
| LYOPHILIZED VIALS OF VCA AND VCAT (K780306) | Gibco Laboratories Life Technologies, Inc. | 1978-03-17 |
| RID SYSTEM-HUMAN C-REACTIVE PROTEIN (K780325) | Icl Scientific | 1978-03-17 |
| PAVLIK HARNESS (K780375) | Biomet, Inc. | 1978-03-15 |
| MINYSTAG MN-1 (K780338) | Lkb Instruments, Inc. | 1978-03-15 |
| BANDAGE SPREADER BLOCK (K780227) | Biomet, Inc. | 1978-03-15 |
| ORTHODONTIC BRACKET PADS (K780170) | Rocky Mountain Orthodontics, Inc. | 1978-03-15 |
| MINIDENTOFLEX NEW POLISHING SYSTEM (K780376) | Cavitron Corp. | 1978-03-14 |
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Every clearance here is in the API, with alerts when new ones post.