Atlas FDA

1981

3,287 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MANNITOL SALT AGAR (K811609)Micro Media Laboratories1981-06-25
ACTH RADIOIMMUNOASSAY KIT (K811565)Immuno Nuclear Corp.1981-06-25
MACCONKEY AGAR (K811611)Micro Media Laboratories1981-06-25
BILE ESCULIN MEDIA (K811600)Micro Media Laboratories1981-06-25
EMIT-ST SERUM PHENOBARBITAL CONTROLS (K811619)Syva Co.1981-06-25
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT (K811566)Immuno Nuclear Corp.1981-06-25
CREATININE TEST (K811664)King Diagnostics, Inc.1981-06-25
UREA AGAR SLANT (K811597)Micro Media Laboratories1981-06-25
CARDIOZYME PLUS CK-MB ITEM #65045 (G) (K811575)Harleco1981-06-25
ALBUMIN TEST (K811662)King Diagnostics, Inc.1981-06-25
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) (K811576)Harleco1981-06-25
POTASSIUM TEST (K811661)King Diagnostics, Inc.1981-06-25
ZIMMER ARTHROSCOPY SYSTEM (K811596)Zimmer, Inc.1981-06-25
EOSIN METHYLENE BLUE AGAR (LEVINE) (K811610)Micro Media Laboratories1981-06-25
EMIT-ST SERUM PHENOBARBITAL CALIBRATOR (K811622)Syva Co.1981-06-25
SALMONELLA SHIGELLA AGAR (K811603)Micro Media Laboratories1981-06-25
BACILLUS CEREUS SELECTIVE(AGAR&SUPP) (K811514)Oxoid U.S.A., Inc.1981-06-24
CASTLE STEAM STERILIZATION INDICATOR (K810614)Sybron Corp.1981-06-24
VCNT ANTIBIOTIC SUPPLEMENT (K811518)Oxoid U.S.A., Inc.1981-06-24
N-TERMINAL HPTH BY RIA (K811418)Immuno Nuclear Corp.1981-06-24
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG (K811545)Kallestad Laboratories, Inc.1981-06-24
EFTEKHAR CENTRALIZING PLUG (K811293)Zimmer, Inc.1981-06-24
THIOGLYCOLLATE MED. W/OUT INDICATOR (K811515)Oxoid U.S.A., Inc.1981-06-24
KALLESTAD R QUANTIPLATE ALT. PATHWAY T. (K811445)Kallestad Laboratories, Inc.1981-06-24
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS (K810999)Cordis Corp.1981-06-24
VCN SUPPLEMENT (K811517)Oxoid U.S.A., Inc.1981-06-24
LEGIONELLA, GROWTH & SELECTIVE, SUPP. (K811516)Oxoid U.S.A., Inc.1981-06-24
FORECASTER (K810832)Forecaster Co.1981-06-24
HUMIDIFIER W/ OR W/OUT ADAPTOR (K811161)Airlife, Inc.1981-06-24
MODEL RS-8100 (K811457)Rinal Systems, Inc.1981-06-23
CRYOPHTHALMIC UNIT (K811244)Keeler Instruments, Inc.1981-06-23
DIGITAL NOISE REDUCER (K811295)Philips Medical Systems (Cleveland), Inc.1981-06-23
X-CELL X-RAY #'S P-75W/P-75M (K811230)X-Cel X-Ray Corp.1981-06-23
MODEL DM-333 DIALYSIS CONTROL STATION (K811444)Extracorporeal Medical Specialities, Inc.1981-06-23
MODEL FUS-1, FLEXIBLE URETEROSCOPE (K811535)American Optical Corp.1981-06-23
CERVICAL SPATULA (K811548)Procedure Products, Inc.1981-06-23
AUTOMATED GASTRIC LAVAGE (K811061)Emergency Medicine1981-06-23
SOMATOM 2N (K811302)Siemens Corp.1981-06-23
7.5 MHZ WP TRANSDUCER (K810748)General Electric Co.1981-06-19
TRYPTIC SOY AGAR W/5% SHEEP BLOOD & EMB (K811474)Biomedia, Inc.1981-06-18
MUELLER HINTON AGAR W/5% SHEEP BLOOD (K811473)Biomedia, Inc.1981-06-18
WILKINS-CHALGREN ANAEROBE AGAR (K811513)Oxoid U.S.A., Inc.1981-06-18
MGN CONNECTING TUBE (K811541)Mgn Medical Manufacturing, Inc.1981-06-18
MACCONKEY AGAR (K811477)Biomedia, Inc.1981-06-18
BOTTLE-TO-BOTTLE (K811268)Medi-Plast Intl., Inc.1981-06-18
REAGENT SET TRIGLYCERIDES (K811553)Boehringer Mannheim Corp.1981-06-18
TSH-P.E.G. (K811558)Nuclear Diagnostics, Inc.1981-06-18
MONOJECT STERILE M503 3CC SYRINGES (K811505)Sherwood Medical Co.1981-06-18
STRUVA & MEDI (K811173)Weco1981-06-18
TIMETER PRODUCED CHEMETRON (NCG) AIR (K811550)Timeter Instrument Corp.1981-06-18
TRYPTIC SOY AGAR W/5% & 10% SHEEP BLOOD (K811475)Biomedia, Inc.1981-06-18
FLEXIGRAM AUTO LOADER SYSTEM (K811525)Electro-Nucleonics Laboratories, Inc.1981-06-18
EMB AGAR, LEVINE (K811478)Biomedia, Inc.1981-06-18
TIMETER PRODUCED OHIO OXYGEN ADAPTOR (K811551)Timeter Instrument Corp.1981-06-18
POLAROID TPX RADIOGRAPHIC FILM (K811352)Polaroid Corp.1981-06-18
HEMAQUIK (K811400)Accra Laboratories, Inc.1981-06-18
KWIK-LAC BETA-LACTAMASE KITS (K811442)Windsor Laboratories, Inc.1981-06-18
STREP-ID PLATE (K811422)Carr-Scarborough Microbiologicals, Inc.1981-06-18
MODEL SP 5507 5-LUMEN THERMODILUTION CAT (K811537)Gould, Inc.1981-06-18
NERVE STIMULATOR MODEL AA 1050 (K811614)Anesthesia Assoc., Inc.1981-06-18
AUTOMATED PHYSIOLOGIC PROFILE MONITOR (K811560)Life Sciences Manufacturing, Inc.1981-06-18
TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR (K811549)Timeter Instrument Corp.1981-06-18
QUINTON CATHETER FINGER GRIP (K811266)Quinton, Inc.1981-06-18
MUELLER HINTON AGAR (K811471)Biomedia, Inc.1981-06-18
DIRECT TESTOSTERONE RIA (K811536)Immuchem Corp.1981-06-18
I.V. BOTTLE (RIDGID) (K811234)Medi-Plast Intl., Inc.1981-06-18
MGN SUCTION CATHETER (K811542)Mgn Medical Manufacturing, Inc.1981-06-18
MUELLER HINTON AGAR, POURED INTO A PLATE (K811472)Biomedia, Inc.1981-06-18
COLBALT ALLOY ORTHOPAEDIC WIRE (K811500)Osteonics Corp.1981-06-18
CHODOLATE AGAR, ENRICHED (K811479)Biomedia, Inc.1981-06-18
HEWLETT-PACKARD VENTILATOR (K810893)Hewlett-Packard Co.1981-06-18
MATELAS COQUILLE LATTREDE TASSIGNY (K811547)Firn-France1981-06-18
THAYER MARTIN AGAR (K811476)Biomedia, Inc.1981-06-18
I.V. PLASTIC BAG (K811233)Medi-Plast Intl., Inc.1981-06-17
GLASS VIALS (K811269)Medi-Plast Intl., Inc.1981-06-16
LAB-TEK JEMBEC G.C. CULTURE SYSTEM (K811382)Miles Laboratories, Inc.1981-06-16
CC-103 (K811527)Anthro-Metrics Corp.1981-06-16
CARDIFF ALDASORBER SYSTEM (K811703)William Harvey Life Products Corp.1981-06-16
#326 PROGRAMMABLE CARD. PULSE GENERATOR (K810885)Cook Pacemaker Corp.1981-06-16
NORTHWESTERN VOICE RESTORATION KIT (K811428)Universal Prosthetics, Inc.1981-06-16
BACILLUM PUMILUS SPORE STRIPS (K810930)Oxoid U.S.A., Inc.1981-06-16
PNEUMATIC DENTAL SCALER (K811145)Innovate, Inc.1981-06-16
RIESS-LUHR (K811113)Allomedic1981-06-16
LUMBO-SACRAL FLEXION ORTHOSIS (K811494)Surgical Appliance Industries, Inc.1981-06-16
BEHIND-THE-EAR HEARING AID (K811344)Maico Hearing Instruments, Inc.1981-06-16
CCS100 CRYOSURGICAL SYSTEM (K811390)Frigitronics of Connecticut, Inc.1981-06-16
WHEELCHAIR RAMPS (K811486)Fred Sammons, Inc.1981-06-16
MAGNETIC RETENTION UNIT (K811237)Universiti Malaya1981-06-16
ANIS GUIDING CANNULA (K811455)American V. Mueller1981-06-16
CHEMATIC BICARBONATE DIALYSATE SYSTEM (K810605)Trimedyne, Inc.1981-06-16
HEARING AID MODEL E1-PL (K811286)Unitron Industries, Inc.1981-06-16
BA-93 (K811407)Deringer-Ney, Inc.1981-06-16
ENHANCE DENTAL RESTORATIVE (K811443)Johnson & Johnson Professionals, Inc.1981-06-16
MINERALS MODIFIED MED. BASE & SOD. GLUT. (K811420)Oxoid U.S.A., Inc.1981-06-16
STIM STAND (K811483)Fred Sammons, Inc.1981-06-16
COHERENT FLOUROTRON MASTER (K811153)Lumenis, Inc.1981-06-16
YOSHIDA AP 100 (K811211)Kaycor Intl., Ltd.1981-06-16
VICON (K811172)Oxford Medilog, Inc.1981-06-16
COLTENE DRS DENTAL RESTORATIVE SYSTEM (K811363)Coltene, Inc.1981-06-16
CERAVITAL CERAMIC OSSICULAR REPL. PROS. (K810707)Xomed, Inc.1981-06-16
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Every clearance here is in the API, with alerts when new ones post.