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32,815 FDA 510(k) clearances · Device class
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| Record | Firm | Date |
|---|---|---|
| TOTAL ESTRIOL RIA KIT (K800036) | Amersham Corp. | 1980-01-21 |
| CENTRIA FSH RIA (K792233) | Union Carbide Corp. | 1980-01-21 |
| ASPERGILLUS SP, ANTISERUM POSITIVE (K792686) | Meridian Diagnostics, Inc. | 1980-01-17 |
| HEMO-WEDGE (K790555) | Parker Laboratories, Inc. | 1980-01-17 |
| COBAS-BIO CENTRIFUGAL ANALYZER (K792671) | Hoffmann-La Roche, Inc. | 1980-01-17 |
| ASPERGILLUS SP, COMPLEMENT FIXATION (K792700) | Meridian Diagnostics, Inc. | 1980-01-17 |
| DOW CORNING/W RIGHT WOUND DRAINAGE SYS (K800014) | Dow Corning Corp. Healthcare Industries Materials | 1980-01-17 |
| PARA-PAK (C&S) (K792712) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ASPERGILLUS SP, ANTISERUM, POSITIVE (K792698) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ELVI MUCAPROTEINS (K792554) | Volu Sol Medical Industries | 1980-01-16 |
| ELVI NON-ESTERIFIED FATTY ACIDS (K792555) | Volu Sol Medical Industries | 1980-01-16 |
| CK-MB (CREATINE KINASE-MB) RIA CONTROL (K792524) | Mallinckrodt Critical Care | 1980-01-16 |
| CENTRIA LH RIA (K792350) | Union Carbide Corp. | 1980-01-16 |
| PONCEAU S STAIN SET (K792550) | Electrophoresis Corp. of America | 1980-01-16 |
| SPECTROPHATOMETER MODELS 2280 & 2380AA (K792557) | The Perkin-Elmer Corp. | 1980-01-16 |
| STERILIZATION PROCESS/PLACENTA BASIN (K792625) | Procter & Gamble Mfg. Co. | 1980-01-16 |
| LEUKOCLIP POROS (K792667) | Beiersdorf, Inc. | 1980-01-16 |
| STERILIZATION PROCESS/BABY BLANKET (K792626) | Procter & Gamble Mfg. Co. | 1980-01-16 |
| LEUKOPOR (K792666) | Beiersdorf, Inc. | 1980-01-16 |
| HYPO-ALLERGENIC PLASTIC TAPE (K792136) | National Patent Development Corp. | 1980-01-16 |
| ACA HIGH DENSITY LIPOPROTEIN CHOLES. (K792509) | E.I. Dupont DE Nemours & Co., Inc. | 1980-01-11 |
| STERILIZATION PROCESS/X-RAY DETECT. SPG (K792630) | Procter & Gamble Mfg. Co. | 1980-01-11 |
| CULTURIA MACCONKEY/COLUMBIA CNA (K792579) | Clinical Convenience Products, Inc. | 1980-01-11 |
| STERILIZATION PROCESS/OUTERWRAP (K792633) | Procter & Gamble Mfg. Co. | 1980-01-11 |
| STERILIZATION PROCESS/T-BINDER (K792629) | Procter & Gamble Mfg. Co. | 1980-01-11 |
| ENTERIC-TEK (K792058) | Flow Laboratories, Inc. | 1980-01-11 |
| SCLERAL POWDER (K791923) | Ocularists , Ltd. | 1980-01-10 |
| MODEL 339 TELECROS WIRELESS CROS (K792463) | Telex Communications, Inc. | 1980-01-09 |
| POST EXTRA SYSTOLIC POSTENTLATOR (K791959) | Medrad, Inc. | 1980-01-09 |
| KODAK X-OMAT RP FILM (K792517) | Eastman Kodak Company | 1980-01-09 |
| KODAK CFN FILM SO-224 (K792178) | Eastman Kodak Company | 1980-01-09 |
| KODAK X-OMAT M20 PROCESSOR, MODEL 2 (K792434) | Eastman Kodak Company | 1980-01-09 |
| SR 301 MEDICAL X-RAY FILM (K792317) | E.I. Dupont DE Nemours & Co., Inc. | 1980-01-09 |
| MODEL 339 TELECROS WIRELESS BICROS (K792462) | Telex Communications, Inc. | 1980-01-09 |
| KODAK X-OMAT G FILM (K792448) | Eastman Kodak Company | 1980-01-09 |
| KODAK X-OMAT M20 PROCESSOR, MODEL 1 (K792435) | Eastman Kodak Company | 1980-01-09 |
| KODAK ORTHO G FILM (K792293) | Eastman Kodak Company | 1980-01-09 |
| TODD HEWITT BROTH (K792423) | Isle Media and Sterile Products, Inc. | 1980-01-09 |
| MODEL 341H (HEARING AID) (K792464) | Telex Communications, Inc. | 1980-01-09 |
| OPERATING TABLES & AMPLINOX 03 (K792569) | Ets Rene Marzet | 1980-01-04 |
| EPIC CANNULA (K792578) | Dental Development Services, Inc. | 1980-01-04 |
| AP-1 AUTO PROGRAMMER (K792590) | Burdick Corp. | 1980-01-04 |
| ENDOVAGE SYRINGE (K792577) | Dental Development Services, Inc. | 1980-01-04 |
| HANSAPOR STERILE (K792360) | Beiersdorf, Inc. | 1979-12-31 |
| DECARBOXYLASE BROTH BASE WITH OR WITH- (K792421) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| SIM MEDIUM (K792420) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| PHENYLETHANOL AGAR (K792593) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| TRYPTIC SOY AGAR W/PHENYLETHANOL & (K792596) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE. (K792594) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| TETRATHIONATE BROTH BASE (K792422) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| H-H SHUNT INTRODUCER (K792639) | Holter-Hausner Intl. | 1979-12-31 |
| SF MEDIUM (SF BROTH, STREPTOCOCCUS (K792595) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| LIFELIFT MODELS ONE AND TWO (K792601) | Corda Int'L Holiday, Inc. | 1979-12-31 |
| VOLU-SOL NMB RETICULOCYTE STAIN (K792496) | Volu Sol Medical Industries | 1979-12-31 |
| VOGEL-JOHNSON AGAR (K792542) | Isle Media and Sterile Products, Inc. | 1979-12-31 |
| DECARBOXYLASE MOELLER BASE WITH OR WITH- (K792425) | Isle Media and Sterile Products, Inc. | 1979-12-27 |
| PLAQUE-X DENTURE CLEANER (K792530) | Nexell Corp. | 1979-12-27 |
| LYSINE IRON AGAR (K792544) | Isle Media and Sterile Products, Inc. | 1979-12-27 |
| RIONET HEARING AID HB-68L (K792506) | Rion Acoustic Instruments, Inc. | 1979-12-27 |
| RIONET HEARING AID HB-32T (K792505) | Rion Acoustic Instruments, Inc. | 1979-12-27 |
| INTRA-ARTICULATED EDGER-PLANER SYSTEM (K792353) | Richard Wolf Medical Instruments Corp. | 1979-12-27 |
| BACTEC BACTERIAL DETECTION SYSTEM (K792575) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-12-27 |
| DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO (K792272) | Dexide, Inc. | 1979-12-27 |
| FEEDING TUBE PLACEMENT STYLET (K792468) | Biosearch Medical Products, Inc. | 1979-12-27 |
| SYSTEM 103 CHEMISTRY ANALYZER (K792361) | Gilford Instrument Laboratories, Inc. | 1979-12-27 |
| CHOCOLATE TELLURITE AGAR (K792424) | Isle Media and Sterile Products, Inc. | 1979-12-27 |
| TRYPTOSE BLOOD AGAR BASE & TRYPTOSE (K792543) | Isle Media and Sterile Products, Inc. | 1979-12-27 |
| CHEM-STRATE TRIGLYCERIDE (K792480) | General Diagnostics | 1979-12-27 |
| REFEREE BFT BLOOD FOR TONOMETRY (K792447) | Analytical Products, Inc. | 1979-12-27 |
| CHEM-STRATE CHOLESTEROL (K792478) | General Diagnostics | 1979-12-27 |
| THE ARALUEN CARRIER (K792566) | Araluen, Inc. | 1979-12-20 |
| TEMPORARY BURN SHEET WITH PERFORATED (K792433) | American Medical Disposable, Inc. | 1979-12-20 |
| POLYPHOS (K792392) | Siemens Corp. | 1979-12-20 |
| SORBIES (K792295) | American Hospital Supply Corp. | 1979-12-20 |
| SKIL-CARE TURN AND HOLD PAD (K792318) | Skil-Care Corp. | 1979-12-20 |
| TOMMY TOES (K792331) | Tommy Toes | 1979-12-20 |
| GIGANTOS 1012 MP (K792393) | Siemens Corp. | 1979-12-20 |
| SPAN AIDS KIT (K792297) | American Hospital Supply Corp. | 1979-12-20 |
| THE VERSA-BED (K792298) | First & Ten, Inc. | 1979-12-20 |
| STANFORD STERILE LAP SPONGES (K792471) | Lukens Corp. | 1979-12-20 |
| POLAROID LAND CAMERA FOR ENDOSCOPY (K792512) | Polaroid Corp. | 1979-12-20 |
| TEMPORARY BURN SHEET WITH PERFORATED (K792432) | American Medical Disposable, Inc. | 1979-12-20 |
| STOMAHESIVE POWDER (K792382) | E. R. Squibb & Sons, Inc. | 1979-12-20 |
| MULTI-AD FLUID DISPENSING SYSTEM (K792227) | National Patent Development Corp. | 1979-12-20 |
| CATHETERIZATION FORCEP (K792494) | C. Intl. | 1979-12-20 |
| BRAIN HEART INFUSION W/PABA, O.1%, (K792276) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-12-19 |
| CULTURIA EMB/COLUMBIA CNA W/5% SHEEP (K792284) | Clinical Convenience Products, Inc. | 1979-12-19 |
| CASTROVIEJO VASCULAR SCISSORS (K792576) | Edward Weck, Inc. | 1979-12-19 |
| MR-VP MEDIUM (K792286) | Isle Media and Sterile Products, Inc. | 1979-12-19 |
| AMS YEAST BIOCHEMICAL CARD (K792231) | Vitek Systems, Inc. | 1979-12-19 |
| IPOS BREAST PROSTHESIS (K792372) | Ipos KG | 1979-12-19 |
| PONCY PAK (K791843) | Poncy, Inc. | 1979-12-19 |
| TRYPTONE BROTH (TRYPTOPHANE BROTH) (K792288) | Isle Media and Sterile Products, Inc. | 1979-12-19 |
| CENTRIX MKIV ENDODONTIC DELIVERY (K792461) | Centrix, Inc. | 1979-12-19 |
| KF STREPTOCOCCUS AGAR (K792287) | Isle Media and Sterile Products, Inc. | 1979-12-19 |
| AMBU PAEDI ANAESTHESIA SYSTEM (K792499) | Narco Air-Shields | 1979-12-19 |
| FETAL CHECK (K792546) | Alta Diagnostics, Inc. | 1979-12-18 |
| GENTAMICIN LIQUID CONTROL SERUM (K792262) | Hemometrix | 1979-12-18 |
| BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MH (K792334) | Danavox, Inc. | 1979-12-18 |
| GENTAMICIN CONTROL SERUM (K792261) | Hemometrix | 1979-12-18 |
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