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32,815 FDA 510(k) clearances · Device class
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| Record | Firm | Date |
|---|---|---|
| TODD HEWITT BROTH (K811339) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| HOWMEDICA FEMORAL PRESSURING SEAL (K811317) | Howmedica Corp. | 1981-05-29 |
| YEAST EXTRACT (K811360) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| SF BROTH (K811331) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| CARDIOPULMONARY BYPASS ACCESSORY EQUIP. (K811348) | Bentley Laboratories, Inc. | 1981-05-29 |
| EC MEDIUM (K811333) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| VIOLET RED BILE AGAR (K811338) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| NATAL-TEC PROGESTERONE (K811369) | Armkel, LLC | 1981-05-29 |
| LYSINE IRON AGAR (K811355) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| TOX TM ANALYZER (K811263) | Abbott Laboratories | 1981-05-29 |
| HEMOGLOBIN POWDER (K811357) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| SCHAEDLER BROTH (K811329) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| GN BROTH (HAJNA) (K811354) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| THIOGLYCOLLATE GELATIN MEDIUM (K811335) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| SIM MEDIUM (K811330) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| AGAR, BACTERIOLOGICAL (K811359) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| MYCOSEL (K811334) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| THIOGLYCOLLATE MEDIUM W/OUT INDICATOR (K811340) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| BRAIN HEART INFUSION W/O DEXTROSE (K811353) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| PANCREATIC HYDROLYSATE OF HEART MUSCLE (K811361) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| TERGITOL 7 AGAR (K811337) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| BRAIN HEART CC AGAR (K811332) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| M-GREEN YEAST & MOLD BROTH (K811336) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| TRYPTONE AZOLECITHIN TWEEN (K811356) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| TCBS AGAR (K811362) | Acumedia Manufacturers, Inc. | 1981-05-29 |
| NATAL-TEC ESTRIOL (K811371) | Armkel, LLC | 1981-05-29 |
| SALMONELLA SHIGELLA AGAR (K811327) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| SCHAEDLER AGAR (K811328) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| SABOURAUD LIQUID, BROTH MODIFIED (K811326) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| SABOURAUD DEXTROSE AGAR (K811325) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| STANDARD METHODS AGAR (K811321) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| POTATO DEXTROSE AGAR (K811322) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| NUTRIENT BROTH (K811323) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| HUMERAL FRACTURE CAST BRACE (K811343) | Deseret Medical, Inc. | 1981-05-28 |
| PHENYLETHANOL AGAR (K811324) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| BODAI SUCTION -SAFE 4 (K811241) | Sontek Industries, Inc. | 1981-05-27 |
| DAVIS & GECK NEEDLE/SHARPS COUNTER (K811191) | Davis & Geck, Inc. | 1981-05-27 |
| TUBMATE (K811301) | American Stair-Glide Corp. | 1981-05-27 |
| CERVICAL SUPPORT (K811297) | Orthomedics | 1981-05-27 |
| MEDTRONIC A2 CLINICAL IMAGING SYSTEM (K811187) | Medtronic Vascular | 1981-05-27 |
| BARALYME CO2 ABSORBENT (K811260) | Allied Healthcare Products, Inc. | 1981-05-27 |
| URETHANE ORTHOPAEDIC CASTING TAPE (K811164) | Hexcel Medical | 1981-05-27 |
| LIQUID CHROMATOGRAPHY COLUMNS (K811304) | Supelco, Inc. | 1981-05-27 |
| RECOH ROOT CANAL IRRIGATOR (K811175) | Koei International, Inc. | 1981-05-27 |
| GASTRIN RADIOIMMUNOASSAY TEST (K810722) | Clinical Assays, Inc. | 1981-05-27 |
| EXECUTIVE COLLAR (K811298) | Orthomedics | 1981-05-27 |
| HITACHI 705 AUTOMATIC BLOOD CHEMISTRY (K811194) | Boehringer Mannheim Corp. | 1981-05-27 |
| EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (K811262) | Zeus Scientific, Inc. | 1981-05-27 |
| OMNI (K811158) | Omni Hearing Systems | 1981-05-27 |
| BYPASS COIL (K811068) | G.D. Searle and Co. | 1981-05-27 |
| CITRATE BUFFER (K811251) | Bioscientific | 1981-05-21 |
| SAF SINGLE-USE AEROSOL FILTER (K811203) | Sorensen Research | 1981-05-21 |
| MARZ-175 (K811199) | Emde Corp. | 1981-05-21 |
| DISPOSABLE UNDERPADS (K811232) | Burina | 1981-05-21 |
| MOLDED POLYSULFONE TRIAL PROSTHESIS (K811205) | Shannon Group | 1981-05-21 |
| INORGANIC PHOSPHORUS REAGENTS (K811222) | Connecticut Diagnostics, Ltd. | 1981-05-21 |
| SELF HEATING DISPOSABLE HEAT PAD (K811206) | Ensar Corp. | 1981-05-21 |
| TECHNICON SMAC II SYSTEM & ACCESSORIES (K811249) | Technicon Instruments Corp. | 1981-05-21 |
| KOVA STRIP 6 (K811219) | Icl Scientific | 1981-05-21 |
| VASOVASOSTOMY STABILIZER PLATFORM DEV (K811223) | Biomet, Inc. | 1981-05-21 |
| SUR-FIT DISPOSABLE FANGE CAP (K811163) | E. R. Squibb & Sons, Inc. | 1981-05-21 |
| SPENCO DERMAL PADS (K811184) | Spenco Medical Corp. | 1981-05-20 |
| ANIS IRRIGATING SPATULA (K810937) | American V. Mueller | 1981-05-15 |
| ARIA II INSULIN RIA (K811144) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-15 |
| MULTIANALYTE CONTROLS, ALL KINDS (K811182) | Fisher Scientific Co., LLC | 1981-05-15 |
| TIGGES SPINAL (K811176) | The Tiggs Co. | 1981-05-15 |
| OSMOMETER MODEL OM-6010 (K811179) | Fiske Med Science | 1981-05-15 |
| URINE PREGNANCY TEST STANDARD/CONTR. PK (K811150) | Mallinckrodt Critical Care | 1981-05-15 |
| ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ (K811180) | American Optical Corp. | 1981-05-15 |
| POSITIVE CLOSURE ANESTHETIC VALVE (K811015) | Orthopedic Systems, Inc. | 1981-05-15 |
| HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (K811011) | Sigma Chemical Co. | 1981-05-15 |
| GAMMA CAMERA (K810974) | Siemens Gammasonics, Inc. | 1981-05-13 |
| BASAL MEDIUM EAGLE W/HANKS' SALTS (K810773) | Dutchland Laboratories, Inc. | 1981-05-13 |
| ALSEVER'S SOLUTION (MODIFIED) (K810783) | Dutchland Laboratories, Inc. | 1981-05-13 |
| DISPOSABLE HOLDER FOR HANCOCK MITRAL (K811235) | Vascor, Inc. | 1981-05-13 |
| PH/BLOOD GAS CONTROL (ABC) (K811143) | Instrumentation Laboratory CO | 1981-05-13 |
| MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE (K810769) | Dutchland Laboratories, Inc. | 1981-05-13 |
| DAHLBERG MODEL AM (K811226) | Dahlberg Electronics, Inc. | 1981-05-13 |
| EARLE'S BALANCED SALTS SOULTION (K810779) | Dutchland Laboratories, Inc. | 1981-05-13 |
| L-GLUTAMINE (K810781) | Dutchland Laboratories, Inc. | 1981-05-13 |
| WATER-TISSUE CULTURE GRADE (K810774) | Dutchland Laboratories, Inc. | 1981-05-13 |
| BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT (K810778) | Dutchland Laboratories, Inc. | 1981-05-13 |
| HEARING AID, UNITRON MODEL C5-H (K811174) | Unitron Industries, Inc. | 1981-05-13 |
| DISPOSABLE HOLDER FOR HANCOCK AORTIC (K811236) | Vascor, Inc. | 1981-05-13 |
| MED. 199(MODIFIED) W/HANKS' SALTS (K810770) | Dutchland Laboratories, Inc. | 1981-05-13 |
| HOYT ECONO-TRAY (K811154) | Hoyt Laboratories | 1981-05-13 |
| ENDODONTIC POST SYSTEMS (K810977) | Preat Corp. | 1981-05-13 |
| MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS (K810768) | Dutchland Laboratories, Inc. | 1981-05-13 |
| PENICILLIN-STREPTOMYCIN MIXTURE (K810776) | Dutchland Laboratories, Inc. | 1981-05-13 |
| TRYPAN BLUE (0.5% IN NORMAL SALINE) (K810782) | Dutchland Laboratories, Inc. | 1981-05-13 |
| MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE (K810772) | Dutchland Laboratories, Inc. | 1981-05-13 |
| L-15 MEDIUM (MODIFIED) (K810771) | Dutchland Laboratories, Inc. | 1981-05-13 |
| SODIUM BICARBONATE (7.5%) SOLUTION (K810780) | Dutchland Laboratories, Inc. | 1981-05-13 |
| ARALUEN HEAD SHIELD (K810868) | Araluen, Inc. | 1981-05-13 |
| BALANCE ARTICULATOR (K811075) | Almore Intl., Inc. | 1981-05-13 |
| RPMI 1640 MEDIUM (K810767) | Dutchland Laboratories, Inc. | 1981-05-08 |
| EPILATRON (K810843) | Electrola | 1981-05-08 |
| AUTOMATIC ELISA READER (K811111) | Artek Systems Corp. | 1981-05-08 |
| LUTEINIZING HORMONE DIRECT RIA KIT 125/I (K811024) | Immunalysis Corporation | 1981-05-08 |
| THE SCOTT DIALMENZENSERT (K810915) | Lone Star Medical Products, Inc. | 1981-05-08 |
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Every clearance here is in the API, with alerts when new ones post.