1
32,815 FDA 510(k) clearances · Device class
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
| Record | Firm | Date |
|---|---|---|
| SAFETY PINS & RUBBER BANDS (K831915) | Ormed Mfg., Inc. | 1983-09-12 |
| UPSHER FIBERBRITE LARYNGOSCOPE (K832650) | Michael S. Upsher | 1983-09-12 |
| CRONEX LO-DOSE MAMMOGRAPHY (K832504) | E.I. Dupont DE Nemours & Co., Inc. | 1983-09-12 |
| ANDROSTENEDIONE TEST SET 125I (K832452) | Wien Laboratories, Inc. | 1983-09-12 |
| BTB LACTOSE AGAR (K832574) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| MCCOY'S 5A #M4892 W/L-GLUTAMINE AND (K832689) | Sigma Chemical Co. | 1983-09-12 |
| SEED AGAR (K832577) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| CIN AGAR (K832588) | Laboratory Products, Inc. | 1983-09-12 |
| FEMORAL CANAL SPONGE (K831886) | Zimmer, Inc. | 1983-09-12 |
| ALT -LTS (K832639) | Electro-Nucleonics Laboratories, Inc. | 1983-09-12 |
| MACCONKEY AGAR MEDIA (K832616) | Carroll Biological Corp. | 1983-09-12 |
| ENDOSCOPIC CAMERA TV W/AUDIO (K832342) | Kamiya Tsusan Kaisha, Ltd. | 1983-09-12 |
| DISPOSABLE NEEDLE HOLDER (K831665) | Medcare Products | 1983-09-12 |
| DISCO SUNGLASSES/HEADBAND SUNGLASSES (K832564) | E-Tay Industrial Co. , Ltd. | 1983-09-12 |
| BASE AGAR (K832576) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| EXTRACT BROTH (K832570) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| GERBER PRECISION CARE BREAST PUMP (K832597) | Gerber Products Co. | 1983-09-12 |
| BLUE AGAR (K832618) | Carroll Biological Corp. | 1983-09-12 |
| TRYPTIC SOY AGAR (K832611) | Carroll Biological Corp. | 1983-09-12 |
| MANNITOL SALT AGAR (K832613) | Carroll Biological Corp. | 1983-09-12 |
| DENTURE CLEANER (K832387) | Tower Laboratories, Ltd. | 1983-09-12 |
| ANTIBIOTIC ASSAY BROTH (K832575) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| BILE ESCULIN AZIDE AGAR (K832571) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| SABOURAUD DEXTROSE AGAR (K832583) | Acuderm, Inc. | 1983-09-12 |
| PLASTIC THUMB FORCEPS (K831664) | Medcare Products | 1983-09-12 |
| MINIMUM ESSENTIAL MED. EAGLE M0268 (K832690) | Sigma Chemical Co. | 1983-09-12 |
| FEMININE HYGIENE DEVICE (K831667) | Snow Willow Co. | 1983-09-12 |
| TUBING KIT 446 (K832584) | Shaban Mfg. Co. | 1983-09-12 |
| IMAGE PROCESSING SYS A3 (K832505) | Metronic, Inc. | 1983-09-12 |
| DULBECCO'S MODIFIED EAGLE #D5523- (K832688) | Sigma Chemical Co. | 1983-09-12 |
| URIAS PRESSURE SPLINTS, & FIRST AID (K831764) | Svenol Andersen | 1983-09-12 |
| GASLINE FILTER #GF-10 (K832411) | American Bentley | 1983-09-12 |
| SF BROTH (K832615) | Carroll Biological Corp. | 1983-09-12 |
| BILE ESCULIN AGAR (K832572) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| C.L.E.D. MEDIUM (K832573) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| CONVEEN DRIP COLLECTOR/NET PANTS (K832489) | Telcam Medical Devices, Inc. | 1983-09-12 |
| MYCOSEL AGAR (K832582) | Acuderm, Inc. | 1983-09-12 |
| DTM-DERMATOPHYTE TEST MEDIUM (K832581) | Acuderm, Inc. | 1983-09-12 |
| THIOGLYCOLLATE MEDIUM (K832619) | Carroll Biological Corp. | 1983-09-12 |
| FIRST AID KITS (K831795) | I M, Inc. | 1983-09-01 |
| HYDROXYPROGESTERONE-17 (K832297) | Diagnostics Biochem Canada, Inc. | 1983-09-01 |
| DAC-CEL HCG-MCA KIT RD52 (K831073) | Wellcome Diagnostics | 1983-09-01 |
| ROGOSA BROTH (K832310) | Oxoid U.S.A., Inc. | 1983-09-01 |
| TCBS AGAR (K832365) | Granite Diagnostics, Inc. | 1983-09-01 |
| PHADEBACT STREP POSITIVE CONTROLS (K832248) | Pharmacia, Inc. | 1983-09-01 |
| ENZYMATIC TRIGLYCERIDES #2000 (K832444) | Stanbio Laboratory | 1983-08-31 |
| PERIODONTAL IRRIGATOR #7620 (K832223) | Vipont Laboratories, Inc. | 1983-08-31 |
| NICE PACK (K832193) | Universal Medical Instrument Corp. | 1983-08-31 |
| HYBRITECH 405-500 NM FILTER MODULE (K832397) | Hybritech, Inc. | 1983-08-31 |
| PRO PULSE PERIODONTAL IRRIGATOR 7618 (K832222) | Vipont Laboratories, Inc. | 1983-08-31 |
| LEADING EDGE OPHTHALMIC KNIFE (K831975) | Surgidev Corp. | 1983-08-31 |
| MONOJET SAMPLETTE ADAPTERS (K832578) | Sherwood Medical Co. | 1983-08-31 |
| RECLINING WHEELS (K832511) | Reclining Wheels | 1983-08-31 |
| ROBIN CORDLESS HANDPIECE (K832063) | Kaycor Intl., Ltd. | 1983-08-26 |
| PHOTON IMMUNOASSAY ANALYZER (K832364) | Hybritech, Inc. | 1983-08-26 |
| ONPG DISCS (K832307) | Oxoid U.S.A., Inc. | 1983-08-26 |
| DISPOSABLE SCISSORS (K831661) | Medcare Products | 1983-08-25 |
| IMMOBILINE SYSTEM LKB 1819 (K830797) | Lkb Instruments, Inc. | 1983-08-24 |
| HS-100 HEADSPACE SAMPLING ACCESSORY (K831387) | The Perkin-Elmer Corp. | 1983-08-24 |
| SPECTROPHOTOMETER #390 (K832206) | Abbott Diagnostics | 1983-08-24 |
| BILE AESCULIN DISCS (K832306) | Oxoid U.S.A., Inc. | 1983-08-24 |
| PB 600 REPEATING DISPENSER (K832202) | Hamilton Co. | 1983-08-24 |
| SPS DISCS (K832305) | Oxoid U.S.A., Inc. | 1983-08-24 |
| THERMOMIXER S213-PHOTOANALYZER S263 (K831649) | Texas Intl. Laboratories, Inc. | 1983-08-24 |
| PRECISION LIQUID DISPENSER (K832205) | Hamilton Co. | 1983-08-24 |
| MICROLAB P (K832204) | Hamilton Co. | 1983-08-24 |
| GAMMA PHOTON GAMMA COUNTER (K832210) | Medical & Scientific Designs, Inc. | 1983-08-24 |
| KINETI COUNT 24 GAMMA COUNTER (K832209) | Medical & Scientific Designs, Inc. | 1983-08-24 |
| AOR X-RAY ALIGMENT PAD (K837776) | Zimmer, Inc. | 1983-08-18 |
| CHROM-PREP (K832201) | Hamilton Co. | 1983-08-16 |
| FITKIT I CHECKUP KIT (K821799) | Patton, Boggs & Blow | 1983-08-16 |
| DIGILAB 350 THE KRAKAU PERIMETER (K832175) | Bio-Rad | 1983-08-16 |
| CHOLESTEROL HIGH PERFORMANCE-K (K832158) | Boehringer Mannheim Corp. | 1983-08-16 |
| DHEA-SULFATE I RIA KIT (K832154) | Diagnostic Systems Laboratories, Inc. | 1983-08-16 |
| PRP-1 REVERSED PHASE COLUMNS FOR HPLC (K832200) | Hamilton Co. | 1983-08-16 |
| ANCHOR BRAND SURGICAL NEEDLES (K831648) | Anchor Products Co. | 1983-08-16 |
| INSPIREASE (K832037) | Key Pharmaceuticals, Inc. | 1983-08-16 |
| FITKIT I CHECKUP KIT (K830340) | Boditestor | 1983-08-16 |
| TEXAS INTERFACE PRESSURE EVALUATOR-TIPE (K831800) | Tee-Kay Applied Technology | 1983-08-16 |
| HC40/HC75 CATION EXCHANGE RESIN (K832199) | Hamilton Co. | 1983-08-16 |
| ORTHOPEDIC CASTING TAPE MAXCAST (K832237) | Cutter Laboratories, Inc. | 1983-08-16 |
| HALL DRILL/REAMER (K832186) | Amsco Co. | 1983-08-12 |
| TUFCOTE EPILATION PROBE (K831048) | Serapis Medical Electronics, Co. | 1983-08-12 |
| POWER OPTIC (K831976) | Ritter Co. | 1983-08-12 |
| OPERATING ROOM TABLES HYDRAULIC (K832340) | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 |
| RIM-HAEMOPHILUS 2 (K832239) | Austin Biological Laboratories | 1983-08-12 |
| TRIANGLE BANDAGE STERILE (K831283) | Pac-Kit Safety Equipment Co. | 1983-08-12 |
| DERMALAND DURAL HOOKS (K832343) | National Fabtronix, Inc. | 1983-08-12 |
| BBL ANAGEL POWDER (K832229) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-08-12 |
| LYSING REAGENT (K832182) | Omega Medical Diagnostics | 1983-08-12 |
| LIPASE REAGENT SET (K831874) | Sterling Biochemical, Inc. | 1983-08-12 |
| API UNISCEPT PLUS 140 INOCULATOR (K831462) | Analytical Products, Inc. | 1983-08-12 |
| BIOCUFF INFUSION BAG PRESSOR (K832377) | Bio-Medical Instruments , Ltd. | 1983-08-12 |
| AQUALIZER MOUTHPIECE (K831793) | Martin D. Lerman | 1983-08-12 |
| HALL RECIPROCATOR (K832188) | Amsco Co. | 1983-08-12 |
| HEARCO C (K831129) | Hear Co., Inc. | 1983-08-12 |
| URINE TOTAL PROTEIN CONTROL (K831526) | Quantimetrix Corp. | 1983-08-12 |
| CLEAR-RITE 3 (K832451) | Richard-Allan Medical Ind., Inc. | 1983-08-12 |
| HALL OSCILLATOR (K832187) | Amsco Co. | 1983-08-12 |
| CONVERTORS FLASH STERILIZING TRAY (K832137) | American Convertors Div., American Pharmaseal | 1983-08-12 |
Track 1 automatically
Every clearance here is in the API, with alerts when new ones post.