Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ACTIVE MODEL AHS HALF SHELL ITE HEARING AID (K910702)Active Electronics, Inc.1991-02-28
GYN-1500 HYSTEROSCOPIC INUFFLATOR (K905706)Circon Acmi1991-02-28
OTT CERVICAL TENACULUM (K910287)Marlo Surgical Technology1991-02-28
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC (K910018)Phonak, Inc.1991-02-28
LAP 3501 HIGH FLOW INSUFFLATOR (K905705)Circon Acmi1991-02-28
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID (K910012)Phonak, Inc.1991-02-28
PHILIPS MODEL S46-OL BTE HEARING AID (K910743)Philips Hearing Instruments Co.1991-02-28
ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER (K905535)Ge Medical Systems Information Technologies1991-02-28
3M MODEL 8243 ITE HEARING AID (K910761)3M Company1991-02-28
ACTIVE MODEL AST CUSTOM ITE HEARING AID (K910700)Active Electronics, Inc.1991-02-28
3M MODEL 8244 ITE HEARING AID (K910762)3M Company1991-02-28
ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID (K910703)Active Electronics, Inc.1991-02-28
3M MODEL 8242 ITE HEARING AID (K910760)3M Company1991-02-28
OVARIAN ASPIRATION/IRRIGATION NEEDLE (K910579)Marlo Surgical Technology1991-02-28
3M MODEL 8241 ITE HEARING AID (K910759)3M Company1991-02-28
VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C (K904364)Varian Assoc., Inc.1991-02-27
DIA HEALING CAP (K902434)Dental Imaging Assoc., Inc.1991-02-27
CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED (K910133)Olympus Corp.1991-02-27
GUILD MAXOX GENERATOR (MAXOX) (K901712)Guild Assoc., Inc.1991-02-27
PHOSPHORUS (INORGANIC) TEST SYSTEM (K910296)Biochemical Trade, Inc.1991-02-27
COBAS ALPHA (K910222)Roche Diagnostic Systems, Inc.1991-02-27
HELENA THROMBOPLASTIN REAGENT, MODIFICATION (K905857)Helena Laboratories1991-02-27
ELECTROPHORESIS CONTROL (K910160)Seradyn, Inc.1991-02-27
SOLUSPONGE - S-99 (K901564)Sie Medical Supply Co., Inc.1991-02-27
DISPOSABLE INTRODUCER SHEATH (K910079)Applied Vascular Devices, Inc.1991-02-27
FLOXIN SUSCEPTIBILITY TEST DISKS (K910412)Difco Laboratories, Inc.1991-02-27
MODIFIED SITE PERISTALTIC FOOTSWITCH (K905620)Site Microsurgical Systems, Inc.1991-02-27
LAP DISCS (K905472)Carr-Scarborough Microbiologicals, Inc.1991-02-27
EXACTECH BIPOLAR HIP PROSTHESIS (K905370)Exactech, Inc.1991-02-27
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM (K904501)Medical Diagnostic Technologies, Inc.1991-02-26
GGT REAGENT (K905618)Amresco, Inc.1991-02-26
ECLIPSE ICA CHOLESTEROL (K905145)Biotope, Inc.1991-02-26
LAPAROSCOPIC ASPIRATION PROBE (K910340)Davol, Inc.1991-02-26
J&B OPTICAL FRAMES (K910626)J & B Optical, Inc.1991-02-26
SUNGLASSES (K902343)Jasco Products Co., Inc.1991-02-26
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI (K905820)E.I. Dupont DE Nemours & Co., Inc.1991-02-26
COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE (K904812)Alpha-Dent1991-02-26
VITREORETINAL INFUSION CANNULA (K904074)Visitec Co.1991-02-26
ES-1000SP II SMART DOP (K903026)Koven and Assoc., Inc.1991-02-26
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL (K910416)Abbott Laboratories1991-02-26
DADE PROTEIN C CLOTTING ASSAY (K903468)Baxter Healthcare Corp1991-02-26
MAXIGOLD (K905327)Ivoclar North America, Inc.1991-02-26
PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 (K910105)International Technidyne Corp.1991-02-26
WLW (K905320)Ivoclar North America, Inc.1991-02-26
HFQ SERIES CONTROLS AND GENERATORS (K905799)Bennett X-Ray Corp.1991-02-26
SLIDEX ROTA-KIT 2 (K895805)Vitek Systems, Inc.1991-02-26
ALBUMIN REAGENT SET (K905776)Biochemical Trade, Inc.1991-02-26
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH (K905254)Depuy, Inc.1991-02-26
HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM) (K904645)Hall Medical Laboratories1991-02-26
WILL-CERAM W (K905329)Ivoclar North America, Inc.1991-02-26
BIOCLONE'S ELEGANCE HCG ELISA KIT (K910420)Bioclone Australia Pty , Ltd.1991-02-26
PLATINUM FOIL, VARIOUS SIZES (K905321)Ivoclar North America, Inc.1991-02-26
COULTER DART AST (GOT) REAGENT (K905771)Coulter Electronics, Inc.1991-02-26
M. CAT. BUTYRATE DISC (K905666)Carr-Scarborough Microbiologicals, Inc.1991-02-26
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST (K910240)Crystal Diagnostics, Inc.1991-02-26
ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) (K903603)Advanced Technology Laboratories, Inc.1991-02-26
DENTHESIVE (K905302)Kulzer, Inc.1991-02-26
EUB-315 (K905294)Hitachi Medical Corp. of America1991-02-25
MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY (K905833)Summit World Trade Corp.1991-02-25
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (K902627)Biometric Research Institute, Inc.1991-02-25
MRP -5000(1): VERSION 2.0 SOFTWARE (K905832)Summit World Trade Corp.1991-02-25
ANTIMICROBIAL CEFOPERAZONE (K910345)Alamar1991-02-25
VISTA VIEWING STATION (K904975)Prism Imaging, Inc.1991-02-25
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE (K905548)Mallinckrodt Medical1991-02-25
SOFTWARE PROGRAM USED W/PRISM PRODUCTS (K904978)Prism Imaging, Inc.1991-02-25
PCM ANESTHESIA (K903991)Siemens Life Support Systems1991-02-25
MODEL 4222 AMBULATORY ECG MONITOR (K904250)Byrncrest Global, Inc.1991-02-25
QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE (K904582)Meadox Surgimed, Inc.1991-02-25
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR (K910237)Medtronic Vascular1991-02-25
CINE'VIEW - STRESS ECHO & IMAGE REVIEW (K904976)Prism Imaging, Inc.1991-02-25
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR (K910112)Telectronics Pacing Systems, Inc.1991-02-25
INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT (K902628)Biometric Research Institute, Inc.1991-02-25
EER ERECTION ENHANCED RESPONDER (K904406)Eer, Inc.1991-02-25
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (K904977)Prism Imaging, Inc.1991-02-25
LP-60 LOW PRESSURE INFLATION DEVICE (K910205)Devices For Vascular Intervention, Inc.1991-02-25
ANTIMICROBIAL CEFTRIAXONE (K910346)Alamar1991-02-25
PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES) (K905765)Tillotson Rubber Co., Inc.1991-02-25
SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. (K904117)Dawn Medical1991-02-25
FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM) (K910439)Lowenkamp Intl., Inc.1991-02-25
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER (K905139)Cathlab Corp.1991-02-25
SARNS TEMPERATURE PROBE AND CONNECTOR (K905686)3M Health Care, Sarns1991-02-25
EMBOLECTOMY CATHETER (K902327)Clincal Instruments Corp.1991-02-25
MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR (K902288)Physio-Control Corp.1991-02-25
SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. (K904118)Dawn Medical1991-02-25
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER (K900677)Cook, Inc.1991-02-22
CK-MB IMMUNOASSAY CONTROL (K905623)Seradyn, Inc.1991-02-22
EMIT II BENZODIAZEPINE ASSAY (K910376)Syva Co.1991-02-22
ECLIPSE ICA ANALYZER (K910302)Biotope, Inc.1991-02-22
ECLIPSE ICA TSH (K910256)Biotope, Inc.1991-02-22
SURGILASE SL 150 SURGICAL LASER SYSTEM (K905006)Surgilase, Inc.1991-02-21
PREP AND OPERATING STAND (K905564)Mcconnell Orthopedic1991-02-21
EBV IGM ELISA TEST (K910042)Gull Laboratories, Inc.1991-02-21
OPUS GENTAMICIN (K905721)Pb Diagnostic Systems, Inc.1991-02-21
CODMAN DISPOSABLE SCALP CLIP APPLIER (K905433)Codman & Shurtleff, Inc.1991-02-21
TITANIUM MESH (K903485)Ruggles Corp.1991-02-21
VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE (K905529)Valleylab, Inc.1991-02-21
ELECTROCAUTERY PROBE (K910334)Wiltek Medical, Inc.1991-02-21
TOTAL PROTEIN REAGENT SET (K905790)Biochemical Trade, Inc.1991-02-21
BIO-GUARD O.R. SCRUB PREP TRAY (K905004)Network Medical Systems, Inc.1991-02-21
STRYKER LAPAROSCOPE (K910132)Stryker Corp.1991-02-21
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Every clearance here is in the API, with alerts when new ones post.