Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (K901156)Granbio, Inc.1990-09-12
ALANINE AMINOTRANSFERASE TEST (K903198)Em Diagnostic Systems, Inc.1990-09-12
ESPI APPLICATOR SLEEVE, #8410 (K903593)Dixon Medical, Inc.1990-09-12
DENTABOND GOLD ALLOY FOR PORCELAIN (K903833)Argen Precious Metals, Inc.1990-09-12
ALERT BED ALARM SYSTEM (K901969)Alertronics, Inc.1990-09-12
KAWASUMI I.V. ADMINISTRATION SET (K896895)Kawasumi Laboratories Co., Ltd.1990-09-12
ESPI REDUCER SLEEVE, #8415 (K903596)Dixon Medical, Inc.1990-09-12
ESPI MICRO SCISSORS, #8150 (K903597)Dixon Medical, Inc.1990-09-12
URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (K903449)Uresil Corp.1990-09-12
ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH (K903592)Dixon Medical, Inc.1990-09-12
ARGICRAFT 2 PALLADIUM SILVER ALLOY FOR PORCELAIN (K903832)Argen Precious Metals, Inc.1990-09-12
PROFESSIONAL MONITOR (K901907)Travis Industries, Inc.1990-09-12
ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204 (K903601)Dixon Medical, Inc.1990-09-12
CLEM TM (K902788)Arbo Medical, Inc.1990-09-12
BI-O.K. STEAM TEST-PAK (K903024)Propper Mfg. Co., Inc.1990-09-12
GENESIS INSUFFLATING CATHETER (K903669)General Medical Co.1990-09-12
DEGUFILL (TM) WHIT-SEALANT (K902742)Degussa AG1990-09-12
COPE NITINOL STONE BASKET (K902945)Cook, Inc.1990-09-12
IV SET (K901949)Jfv, Inc.1990-09-12
RASTRONICS CCI 10/3 HEARING AID ANALYSIS (K902252)Rastronics USA, Inc.1990-09-12
DYNASTY HEARING SYSTEMS INSTRUMENT (K900632)Alastair Granville-Jackson, Mfa, Ed.D.1990-09-12
PATIENT EXAMINATION GLOVES (K903289)Pacificlink Export Industries Private , Ltd.1990-09-12
SPLIT-SECOND INTRODUCER (K902527)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-09-12
THE MAGNUM CHIN IMPLANT (K902285)Applied Biomaterial Technologies1990-09-12
LATEX FINGER COTS (K903073)Dongkuk Trading Co., Ltd.1990-09-12
KAWASUMI SMALL VEIN INFUSION SET (K896896)Kawasumi Laboratories Co., Ltd.1990-09-12
ARGIBOND DENTAL ALLOY FOR PORCELAIN (K903818)Argen Precious Metals, Inc.1990-09-12
ESPI CLAW FORCEP, #8302, 10MM, 30CM (K903595)Dixon Medical, Inc.1990-09-12
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER (K895597)Vas-Cath, Inc.1990-09-12
PHYSICIAN'S CHOICE (K903744)Advance Medical Device, Inc.1990-09-12
ESPI HOOK/UNIVERSAL SCISSORS, # 8101 (K903591)Dixon Medical, Inc.1990-09-12
KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET (K896892)Kawasumi Laboratories Co., Ltd.1990-09-12
ARGICRAFT 1 PALLADIUM SILVER ALLOY FOR PORCELAIN (K903831)Argen Precious Metals, Inc.1990-09-12
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE (K900966)Hitachi Medical Corp. of America1990-09-12
FIBER OPTIC LIGHT SOURCE (K902784)Trek Medical Products, Inc.1990-09-12
MIC ANAL INCONTINENCE TUBE (K902684)Medical Innovations Corp.1990-09-12
ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203 (K903602)Dixon Medical, Inc.1990-09-12
OLYMPUS INORGANIC PHOSPHORUS (K903696)Em Diagnostic Systems, Inc.1990-09-12
KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE (K896893)Kawasumi Laboratories Co., Ltd.1990-09-12
ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201 (K903594)Dixon Medical, Inc.1990-09-12
ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST (K903201)Gen-Probe, Inc.1990-09-12
SYVA MICROTRAK EIA ACCESSORY REAGENTS (K903758)Syva Co.1990-09-12
TRAUMA SLEEVE (K901509)Haz-Med, Inc.1990-09-12
PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH (K902368)Esaote Biomedica Spa1990-09-11
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (K903647)Millipore Corp.1990-09-11
ADG BONE PLUG (K902615)American Design Group, Inc.1990-09-11
SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT (K902621)Lima Intl. Corp.1990-09-11
OXIMETRY PROBE CATHETERS (K901736)Baxter Healthcare Corp1990-09-11
OPTIMATE HEMOGLOBIN A1C (K896830)Heraeus Kulzer, Inc.1990-09-11
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA (K900890)Nidek, Inc.1990-09-10
TIPSTOP(TM) (K896068)Gambro-Hospal, Inc.1990-09-10
SURGICAL LIGHTING-CENTRA 450 (K902864)Sds Dental, Inc.1990-09-10
CUI ARTICULATED SILICONE CHIN (K903327)Cui Corp.1990-09-10
NIDEK, INC. MODEL ADC-8000 DERM (K900925)Nidek, Inc.1990-09-10
DIRECTIGEN FLU A (K902609)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-09-10
COMPANION 318 NASAL CPAP SYSTEM (K903764)Puritan Bennett Corp.1990-09-10
CUSTOMED ARTHROSCOPY PACK (K902887)Customed, Inc.1990-09-10
CUI PREMAXILLARY IMPLANT (K903328)Cui Corp.1990-09-10
STERNOTOMY CABLE, SONGER CABLE SYSTEM (K903676)Danek Medical, Inc.1990-09-10
ABBOTT VISION LYTE (TM) SODIUM (K903188)Abbott Laboratories1990-09-10
TDX FREE T4 CALCULATION (K903383)Abbott Laboratories1990-09-10
MICROSCOPE DRAPE (K902851)Medical Technique Instruments, Inc.1990-09-10
CUI ANATOMICAL SILICONE MALAR (K903329)Cui Corp.1990-09-10
CELL-DYN CALIBRATOR (K902892)Unipath , Ltd.1990-09-10
CYTETTE(TM) CYTOLOGY BRUSH (K902591)Birchwood Laboratories, Inc.1990-09-10
CUSTOMED ORTHOPEDIC II (K902888)Customed, Inc.1990-09-10
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) (K903616)Diagnostic Systems Laboratories, Inc.1990-09-10
CIBA CORNING ACS DIGOXIN IMMUNOASSAY (K902861)Ciba Corning Diagnostics Corp.1990-09-10
BAUMER SURGICAL TABLE (K902865)Sds Dental, Inc.1990-09-10
MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH (K903510)Helm Toy Corp.1990-09-10
IMX FREE T4 CALCULATION (K903384)Abbott Laboratories1990-09-10
AEROMIST II NEBULIZER (K901315)Inhalation Plastics1990-09-10
MODIFICATION TO API UNISCEPT 20GP (K901559)Analytical Products, Inc.1990-09-10
GYREX 2T VERSION 2.1U. (K903028)Elscint, Inc.1990-09-10
CYTOSET(TM) (K902589)Birchwood Laboratories, Inc.1990-09-10
FRAME, SPECTACLE (K903949)Eureka Optics, Inc.1990-09-10
MODIFIED LYOFOAM WOUND DRESSINGS (K895764)Acme United Corp.1990-09-10
LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY (K901127)Lasercomp1990-09-10
ENDOBRUSH(TM) DEVICE; OMNIBRUSH (K897070)Intl. Cytobrush, Inc.1990-09-10
RAD-X GLASSES (K902280)Compudrug1990-09-10
ACID PHOSPHOTASE REAGENT TEST AND KIT (K902543)Crestat Diagnostics, Inc.1990-09-07
IMX FREE T3 CALCULATION (K903432)Abbott Laboratories1990-09-07
SHARGHP INSULIN SYRINGES (K895980)Shargh Pharmaceutical Co., Inc.1990-09-07
NOVAPATH TSH ENZYME IMMUNOASSAY (K903311)Bio-Rad1990-09-07
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION (K903704)Fukuda Denshi USA, Inc.1990-09-07
OHMEDA UNIVERSAL PAC (K901117)Ohmeda Medical1990-09-07
THE ON-GARD CORD-CADDY (K903855)On-Gard Systems, Inc.1990-09-07
DEGUFLEX (R) CS LIGHT (K901866)Degussa AG1990-09-07
F-24 FEMORAL HIP PROSTHESIS (K901687)Med-Tek Corp.1990-09-07
SYNERMED TOTAL PROTEIN REAGENT KIT (K903511)Synermed, Inc.1990-09-07
ABBOTT IMX FREE T4 (K902834)Abbott Laboratories1990-09-07
UREA NITROGEN TEST (K903334)Em Diagnostic Systems, Inc.1990-09-07
ROCHE COBAS READY CREATININE REAGENT (K902561)Roche Diagnostic Systems, Inc.1990-09-07
SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE (K895810)Shargh Pharmaceutical Co., Inc.1990-09-07
LABELLING CHANGES TO IMPRES-MB-X (K903508)Intl. Immunoassay Laboratories, Inc.1990-09-07
AIA-PACK IRI (K903628)Tosoh Corp.1990-09-07
REFLOTRON CREATININE TEST TABS (K903573)Boehringer Mannheim Corp.1990-09-07
MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC (K902976)Medical Consultants Intl. , Ltd.1990-09-07
ENDOSCOPIC HEMOSTATIC LIGATING LOOP (K902731)United States Surgical, A Division of Tyco Healthc1990-09-07
CURITY THORACENTESIS TRAY (K903569)Kendall Healthcare Products Co. Div.Of Tyco Health1990-09-07
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Track 1990 automatically

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