Atlas FDA

1991

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

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RecordFirmDate
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM (K913120)Siemens Medical Solutions USA, Inc.1991-08-16
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO (K912205)Microaire1991-08-16
CERAPLUS (K911674)Metalor Dental USA Corp.1991-08-16
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP (K912654)Osteonics Corp.1991-08-16
OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 (K913121)Continental X-Ray Corp.1991-08-16
CERAPALL 6 (K911669)Metalor Dental USA Corp.1991-08-16
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO. (K912206)Microaire1991-08-16
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY (K913236)Baxter Healthcare Corp1991-08-16
JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION (K912537)Thera Kinetics, Inc.1991-08-16
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (K911217)Serono-Baker Diagnostics, Inc.1991-08-16
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST (K911692)Enzymatics C/O Burditt,Bowles,Radzius & Ruberry1991-08-16
HIGH DENSITY LIPOPROTEIN CHOLESTEROL (K912823)Creative Laboratory Products, Inc.1991-08-16
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C (K911728)Osteonics Corp.1991-08-16
CITATION MEDICAL SCOPE PROCEDURE PACK (K912490)Citation Medical Corp.1991-08-16
JACE MODEL T300 TOE CPM DEVICE (K913227)Thera Kinetics, Inc.1991-08-16
OPUS(R) PROLACTIN TEST SYSTEM (K913280)Pb Diagnostic Systems, Inc.1991-08-16
MEDICAL SAFETY CABLE AND LEAD SYSTEM (K912415)Medtronic Vascular1991-08-16
TRACHEOSTOMY TUBE AND CUFF (K912124)Concord/Portex1991-08-16
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) (K910938)Codman & Shurtleff, Inc.1991-08-16
E-Z CLEAN LAPAROSCOPIC ELECTRODE (K913281)Megadyne Medical Products, Inc.1991-08-16
H.I.STANDARD CALIBRE UPGRADE (K911746)Health Images, Inc.1991-08-16
02-10,001 (K910062)Laser Engineering, Inc.1991-08-16
CANDELA INTRODUCER SHEATH SYSTEM (K912443)Candela Laser Corp.1991-08-16
NOBELPHARMA CERAONE ABUTMENT SYSTEM (K910611)Nobelpharma USA, Inc.1991-08-16
PERCUTANEOUS RETRACTOR KIT (K912903)Applied Urology, Inc.1991-08-16
PLANUSTAR AND DENS NOBILIS DENTURE TEETH (K912989)Wilde-USA, Inc.1991-08-16
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT (K910190)C.R. Bard, Inc.1991-08-16
OLYMOUS XLS XENON LIGHT SOURCE (K912354)Perkinelmer Optoelectronics1991-08-16
PACKS-4 (TM) ANALYZER (K912201)Helena Laboratories1991-08-16
BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF (K910846)C.R. Bard, Inc.1991-08-16
OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS (K905223)Universal Implant Systems, Inc.1991-08-16
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS (K912365)Abbott Laboratories1991-08-16
DIRECTIGEN 1-2-3(TM) HCG TEST (K913122)Quidel Corp.1991-08-16
OPTI-PLAST 5F PTA CATHETERS (K913112)Vas-Cath, Inc.1991-08-16
1.1, 1.2, 1.3 TEMPERATURE PROBES (K912650)Vital Signs, Inc.1991-08-16
ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS (K912337)Megadyne Medical Products, Inc.1991-08-16
DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 (K911166)Diagnostic Ultrasound Corp.1991-08-15
EXPANDACEL NASAL TAMPONS, MODIFICATION (K912524)Surgitrend, Ltd.1991-08-15
GROUP AUDITORY TRAINER,FM RECEIVER (K912356)Phonic Ear, Inc.1991-08-15
TITANIUM CONNECTOR (2 PART) (K910787)Accurate Surgical Instruments Co.1991-08-15
VER-MED A10014 RESTING EKG ELECTRODE & A10021 (K910139)Vermont Medical, Inc.1991-08-15
NORTEC URETERAL STENT (K910691)North American Sterilization & Packaging Co.1991-08-15
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION (K911328)Intertech Resources, Inc.1991-08-15
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 (K911125)Diagnostic Ultrasound Corp.1991-08-15
HORIZON 2000 EEG MONITORING OPTION (K910945)Mennen Medical, Inc.1991-08-15
LAPAROSCOPIC CHOLANGIOCATH (K911487)United States Endoscopy Group, Inc.1991-08-14
ENDOSCOPIC LIGHT SOURCE (K911492)United States Endoscopy Group, Inc.1991-08-14
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED (K912550)Convatec, A Division of E.R. Squibb & Sons1991-08-14
INTRAMEDULLARY HIP SCREW, MODIFICATION (K912162)Smith & Nephew Richards, Inc.1991-08-14
OBSTETRICAL VACUUM CUP (K911326)Gesco Intl., Inc.1991-08-14
COLOR VIDEO CAMERA (K911485)United States Endoscopy Group, Inc.1991-08-14
PLEASURE PLUS (K902772)Medimix Products, Inc.1991-08-14
LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER (K911830)Laserscope1991-08-14
ULCERCARE (K912232)Jobst Institute, Inc.1991-08-14
LAPAROSCOPIC BASKET FLEXIBLE AND RIGID (K911477)United States Endoscopy Group, Inc.1991-08-14
PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST (K911656)Pfizer Hospital Products Group, Inc.1991-08-13
PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE (K912171)Jack James1991-08-13
LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) (K911763)Vasamedics, LLC1991-08-13
DASH IV (K912929)Astro-Med, Inc.1991-08-13
TOPS NEEDLE TIP PROBE & PVC TIP PROBE (K910453)Baxter Healthcare Corp1991-08-13
GENOX MODEL CT-1 (K904639)Pacific Consolidated Industries1991-08-13
FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC (K912767)Microaire Advanced Surgical Products1991-08-13
DENTA SAFE(TM) LATEX EXAMINATION GLOVES (K912999)Dental Care Intl., Inc.1991-08-13
DSL BETA 2 MICROGLOBULIN (DSL 6100) (K912173)Diagnostic Systems Laboratories, Inc.1991-08-13
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP (K912147)Osteonics Corp.1991-08-13
COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM (K912410)Reality Imaging Corp.1991-08-13
LUXUS 132 ND: YAG SURGICAL LASER SYSTEM (K911987)Heraeus Lasersonics, Inc.1991-08-13
ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER (K912029)Coherent Medical Group1991-08-13
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (K912984)Vas-Cath, Inc.1991-08-13
SURG/ASSIST MODEL SA-1 (K912422)Surg-Assist, Inc.1991-08-12
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL (K912455)Baxter Healthcare Corp1991-08-12
AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS (K912738)3M Avi, Inc.1991-08-12
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (K912827)Cala Diagnostics1991-08-12
PLAYTEX NON-DEODORANT/DEODORANT TAMPONS (K912002)Playtex Family Products, Inc.1991-08-12
MONOSCOPY(TM) BRANK, HOOK DISSECTOR (K912862)Dexide, Inc.1991-08-12
MODIFIED SERIES 2100 ENDOSCOPES (K912089)Medical Laser, Inc.1991-08-12
TRANSDUCER PROTECTOR (K910821)Gelman Sciences, Inc.1991-08-12
URESIL GENERAL PURPOSE DRAINAGE CATHETER (K912109)Uresil Corp.1991-08-12
MILENIA TOTAL T4, CATALOG: MKT41,5 (K912541)Diagnostic Products Corp.1991-08-12
PMT METAL LOCATOR, MODEL 3630-1 (K911886)Pmt Corp.1991-08-12
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL (K912295)Kinamed, Inc.1991-08-12
CHOLINESTERASE TEST KIT (K912148)Crestat Diagnostics, Inc.1991-08-12
MAGIC LITE TSH (HS) IMMUNOASSAY (K912583)Ciba Corning Diagnostics Corp.1991-08-12
OPUS(R) ROZO (K911834)Pb Diagnostic Systems, Inc.1991-08-12
REFLOTRON CREATININE TEST TABS (K913105)Boehringer Mannheim Corp.1991-08-12
ERECAID(R) SYSTEM PLUS (K912736)Osbon Medical Systems, Ltd.1991-08-12
FSH IRMA IMMUNOMAG (K912804)Pantex, Div. Bio-Analysis, Inc.1991-08-12
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ (K913107)Roche Diagnostic Systems, Inc.1991-08-12
BIOTROL UIBC REAGENT (K912795)Biotrol, USA, Inc.1991-08-12
DUNLAP HEAT PAD (K911195)Home Healthcare Products, Inc.1991-08-12
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG (K911790)Medtronic Vascular1991-08-12
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA (K911903)Pharmacia, Inc.1991-08-12
ROCHE REAGENT FOR ETHANOL (K913125)Roche Diagnostic Systems, Inc.1991-08-12
ROCHE REAGENT FOR AMMONIA (K913124)Roche Diagnostic Systems, Inc.1991-08-12
ABUSCREEN ONLINE FOR THC (50 AND 100) (K912574)Roche Diagnostic Systems, Inc.1991-08-12
SLIDEX MENINGITE-KIT 5 (K910210)Vitek Systems, Inc.1991-08-12
STASIS BUTTON PRSSURE DEVICE (K912765)Arch Development Group1991-08-12
DIALYSIS TRANDSDUCER PROTECTOR (K911658)Tico Medical Instruments, Inc.1991-08-12
BRAIDED HIGH PRESSURE CATHETER CONNECTOR (K905415)The R Group1991-08-12
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH (K911870)Scimed Life Systems, Inc.1991-08-12
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Track 1991 automatically

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