Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODIFICATION TO IV SPIKE (K921860)Mcgaw, Inc.1992-07-30
ULTRABLADE (K921167)Micron Technology, Inc.1992-07-30
LEGIONELLA STAT IGG/IGM TEST KIT (K911356)Whittaker Bioproducts, Inc.1992-07-30
SYNTHETIC ABSORBABLE SUTURE, UNDYED (K920437)ETHICON, Inc.1992-07-30
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II (K922904)Reagents Applications, Inc.1992-07-30
BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET (K922354)Med Institute, Inc.1992-07-30
HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM (K922184)Hewlett-Packard Co.1992-07-30
TURKEL THORACENTESIS SYSTEM (K922614)Symbiosis Corp.1992-07-30
ZITHROMAX (K922792)Difco Laboratories, Inc.1992-07-30
RESTCUE CC (K922973)Support Systems Intl.1992-07-30
HAIR TRONICS MODEL HT8000 (K915845)Global Tronics Intl., Inc.1992-07-29
QQUADRATURE LUMBAR CONTOUR COIL (K922006)Magnetic Research, Inc.1992-07-29
ITC BUNJI COIL (MODIFICATION) (K920324)Interventional Therapeutics Corp.1992-07-29
IL TEST ALPHA-1-ANTITRYPSIN (AAT) (K920005)Instrumentation Laboratory CO1992-07-29
IL TEST(TM) HAPTOGLOBIN (HPT) (K915829)Instrumentation Laboratory CO1992-07-29
SPECTACLE FRAMES (K922001)Otego Optical, Inc.1992-07-28
KTP/532 & KTP/YAG SURGICAL LASERS (K913244)Charles L. Rose and Co., Inc.1992-07-28
COBAS CORE IMMUNOCHEMISTRY SYSTEM (K921180)Roche Diagnostic Systems, Inc.1992-07-28
NOBLES-LAI IMAGING SYSTEM (K920026)Nobles-Lai Engineering, Inc.1992-07-28
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921302)Vitek Systems, Inc.1992-07-28
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (K921421)Pro-Lab, Inc.1992-07-28
LASER-6 (K921096)Laser Endo Technic1992-07-28
MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM (K922084)Gen Trak, Inc.1992-07-28
BILIBLANKET LIGHT METER (K910571)Ohmeda Medical1992-07-28
LORACARBEF 30MCG DISK (K922791)Difco Laboratories, Inc.1992-07-28
ENOXACIN (K922794)Difco Laboratories, Inc.1992-07-28
WAKO AUTOKIT RF (K922151)Wako Chemicals USA, Inc.1992-07-28
PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR (K915170)Pymah Corp.1992-07-28
LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR) (K922563)Raco Products Co.1992-07-28
MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL (K922000)Mri Devices Corp.1992-07-28
ACS APCT REAGENT (K921118)Analytical Control Systems, Inc.1992-07-28
CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO (K915201)Bennett X-Ray Corp.1992-07-28
MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM (K922085)Gen Trak, Inc.1992-07-28
POINTE 750 GLYCOMETER (K920449)Pointe Scientific, Inc.,1992-07-28
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K922168)Alamar Biosciences Laboratory, Inc.1992-07-28
ORTHODONTIC ELASTICS BANDS (K920645)Masel Industries, Inc.1992-07-28
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT (K922885)Olympus Corp.1992-07-28
SYNELISA TPO ANTIBODIES (K921787)Elias U.S.A., Inc.1992-07-28
OLYMPUS ALANINE AMINOTRANSFERASE REAGENT (K922884)Olympus Corp.1992-07-28
CEFZIL (K922793)Difco Laboratories, Inc.1992-07-28
LAPAROSCOPIC RETRACTOR SYSTEM (K921006)Laparomed Corp.1992-07-28
HEMO-BAND (K920614)Innovations IN Access, Inc.1992-07-27
SUNGLASSES (K920836)A Toz Importing Co.1992-07-27
CATHETER TWO STAGE VENOUS RETURN (K915268)Dlp, Inc.1992-07-27
AMERICAN MEDICAL MFG. LUMBAR CPM (K922493)American Medical Corp.1992-07-27
BIVONA TRACHEAL T-TUBE STENT (K920604)Bivona Medical Technologies1992-07-27
COULTER MAXM W/ AUTOLOADER (K922704)Coulter Electronics, Inc.1992-07-27
NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION (K921937)Nova Biomedical Corp.1992-07-27
CAG-02A (K922098)Toshiba America Medical Systems, In.C1992-07-27
PHARMACIA CMV IGM ELISA (K921011)Pharmacia Diagnostics, Inc.1992-07-27
DADE RECOMBOPLASTIN S (K921326)Baxter Diagnostics, Inc.1992-07-27
PEAK FLOW MONITOR (K915059)Spirometrics, Inc.1992-07-27
VENTREX ALLERGEN DISC (K922538)Hycor Biomedical, Inc.1992-07-27
XENON LIGHT SOURCE AND ACCESSORIES (K921390)Coopervision Surgical1992-07-27
ATC725, ATC525, AND AP300 (K922165)Gendex Corp.1992-07-27
ACE 100 DEGREES TUBULAR PLATE (K920738)Ace Orthopedic Manufacturing Co.1992-07-27
HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS (K920222)Akers Research Corp.1992-07-27
OPTICAL FRAMES (K923177)A Toz Importing Co.1992-07-27
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS (K922996)Chiron Vision Corp.1992-07-27
HYPO-GARD (K921913)Epi Medical Products, Inc.1992-07-24
JAGWIRE(TM) RECANALIZATION GUIDEWIRE (K922302)Boston Scientific Corp1992-07-24
MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001 (K914772)Medix Corp.1992-07-24
THE TERMINATOR (K922535)Top End Wheelchair Sports, Inc.1992-07-24
LASERSCOPE'S MICROSPOT DERMASTAT (K914918)Laserscope1992-07-24
ATRAUMATIC SPECIAL SPROTTE NEEDLE (K911221)Pajunk GmbH1992-07-24
MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE (K920135)Medroyal, Inc.1992-07-24
CURASOL(TM) WOUND DRESSING (K921810)Healthsouth Medical Center1992-07-23
BIOTRACK PHENYTOIN TEST CARTRIDGE (K915755)Biotrack, Inc.1992-07-23
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K921435)Gen-Probe, Inc.1992-07-23
OSTEO TIBIA NAIL (K922196)Osteo AG1992-07-23
CUFF-M (K921997)Lorin Medical, Inc.1992-07-23
DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED (K913302)Carwild Corp.1992-07-23
COMPASEP (K920649)Wilde-USA, Inc.1992-07-23
TURBINATE NASAL SPLINT (K921202)Smith & Nephew Richards, Inc.1992-07-23
OSTEO KIRSCHNER WIRE (K922193)Osteo AG1992-07-23
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL (K922410)Scimed Life Systems, Inc.1992-07-23
BICUT (K915608)Berchtold Holding GmbH1992-07-23
MAX-E-VAC (K920217)Leisegang Medical, Inc.1992-07-23
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 (K922024)Helena Laboratories1992-07-23
IL TEST BILIRUBIN TOTAL/DIRECT (K920653)Instrumentation Laboratory CO1992-07-23
OSTEO STEINMANN PIN (K922194)Osteo AG1992-07-23
VLC DYCAL II (K922721)Dentsply Intl.1992-07-23
DEROYAL TRANSPARENT FILM DRESSIGN (K920796)Deroyal Industries, Inc.1992-07-23
MERKUR 4000 (K920575)F.M. Wiest USA, Inc.1992-07-23
OSTEO FEMORAL NAIL (K922195)Osteo AG1992-07-23
BIOTRACK CARBAMAZEPINE TEST CARTRIDGE (K915756)Biotrack, Inc.1992-07-23
NASAL SEPTAL SPLINT (K921195)Smith & Nephew Richards, Inc.1992-07-23
URETHRAL ELECTRODE SHEATH (K915219)Applied Urology, Inc.1992-07-23
CLOSED CHAIN ATTACHMENT, MODEL #820-520 (K923350)Biodan Medical Systems, Ltd.1992-07-23
LATEX EXAM/SURGICAL GLOVES (K920202)Redsun Latex , Ltd.1992-07-23
ABBOTT STREP A CONTROLS (K922490)Abbott Laboratories1992-07-22
AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K923021)Tosoh Corp.1992-07-21
MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 (K920071)Medical Devices, Inc.1992-07-21
SALINE SOLUTION- STERILE (K922033)Trinity Laboratories, Inc.1992-07-21
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION (K922139)Syva Co.1992-07-21
VISTA ULTRASENSITIVE HTSH ASSAY (K922138)Syva Co.1992-07-21
COOLING/HEATING THERAPY DEVICE (K921540)Tempacure Home Care1992-07-21
LATEX PROPHYLACTIC (CONDOM) (K912405)Hevealactics Intl. Sdn Bhd1992-07-21
POTTY PAGER (K921431)Ideas For Living1992-07-21
SUNGLASSES (K922121)Pavilion Investment , Ltd.1992-07-21
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Track 1992 automatically

Every clearance here is in the API, with alerts when new ones post.