Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MAGNETOM VISION (PROJECT 016) (K945517)Siemens Medical Solutions USA, Inc.1995-10-07
ARGESOL 600 (K954360)Argen Precious Metals, Inc.1995-10-07
ICU STOPCOK WITH EXTENSION TUBING (K953573)Icu Medical, Inc.1995-10-07
COMPUTER DYNO/GONIO/MYO GRAPHY (K942965)Infotronic Medical Engineering1995-10-07
ARGENCO 68M (K954361)Argen Precious Metals, Inc.1995-10-07
32MM NICKEL PLATED DISC ELECTRODE (K953220)Chalgren Enterprises, Inc.1995-10-06
AXSYM AMPHETAMINE/METHAMPHETAMINE II (K953115)Abbott Laboratories1995-10-06
TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM (K953284)Trend Scientific, Inc.1995-10-06
22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN (K953219)Chalgren Enterprises, Inc.1995-10-06
AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM) (K951684)Digital Air Corp.1995-10-06
SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES (K953242)Symbiosis Corp.1995-10-06
OPUS HCG CONTROLS (K954144)Behring Diagnostics, Inc.1995-10-06
LEEP SYSTEM 1000 (K952483)CooperSurgical, Inc.1995-10-06
ANGIOREX (K954309)Toshiba Medical Systems1995-10-06
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING (K952775)Deroyal Industries, Inc.1995-10-06
AFFINITY ARTERIAL BLOOD FILTER (K952532)Avecor Cardiovascular, Inc.1995-10-06
SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 (K952661)Surgical Laser Technologies, Inc.1995-10-06
DIASTAT VASCULAR ACCESS GRAFT (K953287)W. L. Gore & Associates, Inc.1995-10-06
MDA SIMPLASTIN LS (K952608)Organon Teknika Corp.1995-10-06
DIASTAT VASCULAR ACCESS GRAFT (K953288)W. L. Gore & Associates, Inc.1995-10-06
QBC CENTRIFUGAL HEMATOLOGY CONTROL (K954137)R&D Systems, Inc.1995-10-06
CLM LARYNGOSCOPE (K953179)Penlon , Ltd.1995-10-06
UNITRON MODEL SOUND F/X (K954430)Unitron Industries, Inc.1995-10-06
HOLLISTER HYDROCOLLOID WOUND DRESSING (K954235)Hollister, Inc.1995-10-06
COULTER Z 1 (K952308)Coulter Corp.1995-10-06
ZYMED TELEMETRY SYSTEM; MODEL T8010 (K951370)Zymed Medical Instrumentation1995-10-06
UNISCAN (K953398)Merlin Engineering Works, Inc.1995-10-06
TOX PERFECT A TUBE (K953393)Chimera Research & Chemical, Inc.1995-10-06
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS (K953403)Deroyal Industries, Inc.1995-10-06
PROFILE 7000 C-SPINE COIL (K943440)Us Asia Instruments, Inc.1995-10-06
SAUER ENDOSCOPE GUIDE AND INTUBATION AID (K954125)KARL STORZ Endoscopy-America, Inc.1995-10-06
BRAUN DIACAN(R) FISTULA NEEDLES (K945850)B. Braun of America, Inc.1995-10-06
QBC ACCUTUBE (K953340)Becton Dickinson Diagnostic Instrument Systems1995-10-05
ALTRA FLUX 110 HEMODIALYZER (K952978)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
KSEA MODEL 203200 20 UNIMAT (K953190)KARL STORZ Endoscopy-America, Inc.1995-10-05
CARDIMA, INC. FORERUNNER (K951603)Cardima, Inc.1995-10-05
WAKO AUTOKIT GLUCOSE (K950172)Wako Chemicals USA, Inc.1995-10-05
W&H 100 SERIES LOW SPEED (K944719)A-Dec, Inc.1995-10-05
HAWN UNIVERSAL (K953158)Metal-Tech1995-10-05
KARL STORZ FLEXIBLE HYSTERSCOPE (K952779)KARL STORZ Endoscopy-America, Inc.1995-10-05
W&H ROTO QUICK COUPLINGS (K945734)A-Dec, Inc.1995-10-05
THERMOTEK H-300 (K945853)Thermotek, Inc.1995-10-05
FLEXMATE K500 (K950755)Breg, Inc.1995-10-05
OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) (K954094)G.W.B. Intl., Ltd.1995-10-05
INSTANT COLDGEL (K953541)Prism Technologies, Inc.1995-10-05
CATHETER, BALLOON TYPE (K950398)Interventional Therapeutics Corp.1995-10-05
VANGUARD XR-350 CINEANGIOGRAM PROJECTOR (K953563)Jamieson Film Co.1995-10-05
MICRO-TOUCH* LATEX SURGICAL GLOVES (K954049)Johnson & Johnson Medical, Inc.1995-10-05
UROPUMP TUBE & DAMPING CHAMGER (K953451)Life-Tech Intl., Inc.1995-10-05
POSITIVE LUPUS ANTICOAGULANT PLASMA (K945856)George King Bio-Medical, Inc.1995-10-05
ALTR NOVA 110 HEMODIALYZER (K952983)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
ACUFEX TAG DELIVERY SYSTEM (K953276)Acufex Microsurgical, Inc.1995-10-05
IOLAB/SITE PERISTALTIC MODULE (K944995)Chiron Vision Corp.1995-10-05
TESTPACK PLUS HCG URINE (K954029)Abbott Laboratories1995-10-05
W&H 900 INCOLIGHT LT HANDPIECE (K944718)A-Dec, Inc.1995-10-05
VISUALINE II BENZODIAZEPINES (K953105)Sun Biomedical Laboratories, Inc.1995-10-05
AVL OMNI ANALYZER (K954018)Avl Scientific Corp.1995-10-05
CARBON DIOXIDE - DST (K952410)Trace America, Inc.1995-10-05
EXTERNAL FIXATOR (K952330)Acu Med, Inc.1995-10-05
ALTREX 110 HEMODIALYZER (K952982)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
IMPERVA FLUOROBOND (K953612)Shofu Dental Corp.1995-10-04
STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM (K953436)Strato/Infusaid, Inc.1995-10-04
EBICE (K953532)Electro-Biology, Inc.1995-10-04
ERBOTOM ICC BIPOLAR (K953159)Erbe USA, Inc.1995-10-04
INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM (K946311)Calcitek, Inc.1995-10-04
PORT-A-CATH ACCESS KIT (K952201)Medi-Flex Hospital Products, Inc.1995-10-04
CHEMMATE(TM) L26 (CD20) (K950151)Biotek Solutions, Inc.1995-10-04
IMPERVA ENSURABOND (K953613)Shofu Dental Corp.1995-10-04
ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE (K952072)Zomed Intl.1995-10-04
STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS (K953256)Strato/Infusaid, Inc.1995-10-04
1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION (K951371)Siemens Medical Solutions USA, Inc.1995-10-04
CC RIDER, MODEL ME180 (K951916)Mettler Electronics Corp.1995-10-04
3DSEE (K951646)Intl. Telepresence Corp.1995-10-04
APOLIPOPROTEIN CALIBRATOR (APO-CAL) (K953979)Beckman Instruments, Inc.1995-10-03
AUTO SUTURE* MODIFIED LINEAR STAPLER** (K952239)United States Surgical, A Division of Tyco Healthc1995-10-03
FIRST RESPONSE OVULATION PREDICTOR TEST (K953581)Armkel, LLC1995-10-03
MINISTRIP HCG (K951705)International Newtech Development, Inc.1995-10-03
MICROPRIME (K953504)Danville Engineering, Inc.1995-10-03
DMA GLUCOSE HEXOKINASE U.V. PROCEDURE (K952437)Data Medical Associates, Inc.1995-10-03
NONPOWERED NEUROSURGICAL INSTRUMENT (K953173)United States Surgical, A Division of Tyco Healthc1995-10-03
ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE (K952553)Alpha Medica1995-10-03
SPECTACLE SUN GLASSES (NON PRESCRIPTION) (K954173)Monte Carlo Eyewear, Inc.1995-10-03
HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24 (K950821)Hewlett-Packard Co.1995-10-03
KENSORB (K953830)Kentron Health Care, Inc.1995-10-03
LMT 20 AA LASER SURGICAL SYSTEM (K952046)Laser Max Medical Technologies Corp.1995-10-03
BRANEMARK RADIOGRAPHIC DEPTH GUAGE (K953435)Nobelpharma USA, Inc.1995-10-03
LMT 40 AA LASER SURGICAL SYSTEM (K952047)Laser Max Medical Technologies Corp.1995-10-03
BRYAN POSTERIOR SPINAL FIXATOR (BPSF) (K953416)Arcan Orthopaedic Corp.1995-10-03
LMT 20 HH LASER SURGIVAL SYSTEM (K952045)Laser Max Medical Technologies Corp.1995-10-03
CALVITRON HAIR TRANSPLANT SYSTEM (K952737)Medicamat S.A.1995-10-03
DORNIER THERMAFOCUS 360 FIBER (K950996)Daimler-Benz Aerospace1995-10-03
ABBOTT IMX PROLACTIN(MODIFICATION) (K953656)Abbott Mfg., Inc.1995-10-03
SIEMENS SONOLINE 4XX (K946179)Siemens Medical Solutions USA, Inc.1995-10-03
SHROUDED PLASTIC CANNULA (K952834)Medical Associates Network, Inc.1995-10-03
VASPORT VASCULAR ACCESS PORT (K953571)Gish Biomedical, Inc.1995-10-02
QUICKVUE ONE-STEP ALLERGEN SCREEN (K950728)Quidel Corp.1995-10-02
ULTRA-SENSITIVE ESTRADIOL (K953605)Diagnostic Systems Laboratories, Inc.1995-10-02
GAUZE SPONGE (K953812)Remington Medical, Inc.1995-10-02
SNOREMASTER (K954128)D.D.S., Inc.1995-10-02
BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 (K954278)Beta Medical Products, Inc.1995-10-02
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Every clearance here is in the API, with alerts when new ones post.