Atlas FDA

2009

3,008 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS (K093392)Navilyst Medical, Inc.2009-12-31
MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES (K091541)Sequal Technologies Co., Ltd.2009-12-31
MORPHEUS (K082249)Meibach Tech Ltda2009-12-31
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) (K090920)The Binding Site, Ltd.2009-12-30
KNEEHAB XP CONTROLLER, MODEL 411 (K092791)Bio-Medical Research, Ltd.2009-12-30
MEDTRONIC DENTAL TCP (K092087)Medtronic Sofamor Danek USA, Inc.2009-12-30
STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) (K090986)Dfine, Inc.2009-12-30
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION (K092906)STERIS Corporation2009-12-30
FONIX ,MODEL 8000 (K093006)Frye Electronics, Inc.2009-12-30
ENABLER-P CATHETER SYSTEM, MODEL 3000 (K092174)Endocross, Ltd.2009-12-30
BANTAM,48XXXXXX, 50XXXXXX (K093139)ClearStream Technologies , Ltd.2009-12-30
MARS HOLTER ANALYSIS WORKSTATION (K093141)Ge Medical Systems Information Technologies2009-12-29
MILTEX MEMBRANE TACK KIT (K092855)Miltex, Inc.2009-12-29
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 (K092588)Andon Health Co, Ltd.2009-12-29
PIEZOSURGERY 3; OSSTEM PIEZO (K091227)Piezosurgery S.R.L.2009-12-29
LIPOSE DISPOSABLE CANNULA (K093067)Lipose Corp.2009-12-29
SYNTHES MATRIX SYSTEM (K092929)Synthes (Usa)2009-12-29
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 (K091585)Kci USA, Inc.2009-12-29
STARCARE HANDPIECE MAINTENANCE UNIT (K093072)Dentalez, Inc.2009-12-28
HUMAN IGD KIT FOR USE ON SPAPLUS (K092450)The Binding Site2009-12-28
SIMPLER TOADSTOOL MINI IMPLANT (K092674)Pan Global Implant2009-12-28
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K091851)Gx Corporation Sdn Bhd2009-12-28
PENTEX EC-3890LI (K093037)Pentax Medical Company2009-12-28
LIFEDOP MODEL 300ABI (K093393)Summit Doppler Systems, Inc.2009-12-24
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (K090959)D'Antonio Consultants International, Inc. (Dci)2009-12-24
PARADIS VASO SHIELD (K093551)Spinemedica, LLC2009-12-24
PROTON THERAPY MULTILEAF COLLIMATOR (K093250)Varian Medical Systems2009-12-24
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 (K093035)Taidoc Technology Corporation2009-12-24
AVS PL PEEK SPACERS (K093704)Stryker Corp.2009-12-23
INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 (K093675)Vertebral Technologies, Inc.2009-12-23
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART (K093616)Carefusion 22002009-12-23
VASCUVIEW TAP ULTRASOUND SYSTEM (K093613)Escalon Medical Corp.2009-12-23
FORESEE HOME (K091579)Notal Vision , Ltd.2009-12-23
SIMUPLAN TREATMENT PLANNING SYSTEM (K093391)Simuplan S.L.2009-12-23
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 (K092510)Andon Health Co, Ltd.2009-12-23
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT (K092803)Cardo Medical Corp.2009-12-23
RAPID-I (K090832)Vitrolife Sweden AB2009-12-23
TRIA HAIR REMOVAL LASER SYSTEM (K090820)Spectragenics, Inc.2009-12-23
ZOLL E SERIES WITH CPRREADYCHARGE (K091265)Zoll Medical Corporation, World Wide Headquarters2009-12-23
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING (K090690)Maquet Cardiopulmonary, AG2009-12-23
O-SCAN MR SYSTEM (K092469)Esaote, S.p.A.2009-12-23
PATRIOT TRANSCONTINENTAL LLIF SPACER (K093242)Globus Medical, Inc.2009-12-23
SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES (K091644)Synthes (Usa)2009-12-23
RADIONUCLIDE BRACHYTHERAPY SOURCE (K093663)C.R. Bard, Inc.2009-12-23
CERVICORE CORPECTOMY CAGE (K091426)Verticor, Ltd.2009-12-23
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS (K091749)Kimberly-Clark Corp.2009-12-23
ZIEHM SOLO (K092438)Ziehm Imaging, Inc.2009-12-23
SWIFT-LOCK ANCHOR, MODEL 1192 (K092371)Advanced Neuromodulation Systems2009-12-23
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 (K090555)Maquet Cardiopulmonary, AG2009-12-23
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 (K093452)Andon Health Co, Ltd.2009-12-23
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K093077)Alphatec Spine, Inc.2009-12-23
OTI-SCAN 3000 (K092837)Opko Instrumentation, Inc.2009-12-23
VENOUS HARDSHELL CARDIOTOMY RESERVIORS (K090534)Maquet Cardiopulmonary, AG2009-12-23
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (K093415)Diagnostic Hybrids, Inc.2009-12-23
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO (K093720)Boston Scientific Corp2009-12-23
ONTEX TAMPON (UNSCENTED) (K090819)Ontex International NV2009-12-23
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE (K091729)Etex Corp.2009-12-23
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (K093098)Arkray, Inc.2009-12-23
CONMED LINVATEC INTERCEPT IMPLANT (K092998)Linvatec Corp.2009-12-23
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX (K093636)Boston Scientific Corp2009-12-23
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (K093167)Diagnostica Stago, Inc.2009-12-22
PATHWAY IVB/VBR (K092904)Custom Spine, Inc.2009-12-22
VPAP TX (K092186)Resmed, Ltd.2009-12-22
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE (K091762)Covidien2009-12-22
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093439)Tangshan Pufa Plastic Products Co., Ltd.2009-12-22
ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT (K093483)Astra Tech, Inc.2009-12-22
STRAUMANN MODIFIED DENTAL ABUTMENT (K091701)Institut Straumann AG2009-12-22
CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM (K091926)Choicespine, LP2009-12-22
ENAMELITE ACRYSEAL SPRAY SEALANT (K093019)Enamelite, LLC2009-12-22
STA LIATEST FREE PS (K092170)Diagnostica Stago, Inc.2009-12-22
BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES (K093025)Bovie Medical Corporation2009-12-22
IBA PROTON THERAPY SYSTEM, PROTEUS 235 (K092796)Ion Beam Applications S.A.2009-12-22
VERTECEM (K090435)Teknimed, S.A.2009-12-21
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS (K091543)Smith & Nephew, Inc.2009-12-21
AMSCO WARMING CABINET (K092823)STERIS Corporation2009-12-18
SMARTWAND-DTX (K093557)Clearcount Medical Solutions2009-12-18
LED LAMP OR OTHER (K092883)Intravista Medical Systems, Inc.2009-12-18
QUART ARTERIAL FILTER WITH SOFTLINE COATING (K090518)Maquet Cardiopulmonary, AG2009-12-18
HLM TUBING SET WITH SOFTLINE COATING (K090533)Maquet Cardiopulmonary, AG2009-12-18
PERIOPHIL BIPHASIC (K092788)Cytophil, Inc.2009-12-18
INTELLIBRIDGE SYSTEM (K093177)Philips Medical Systems2009-12-18
RESPIRONICS PERFORMAX SE TOTAL FACE MASK (K092648)Respironics Inc., Sleep & Home Respiratory Group2009-12-18
AF 840 PH.I.S.I.O. ARTERIAL FILTER (K093601)Sorin Group Italia S.R.L.2009-12-18
SMART TENS, MODEL: D-BC05T (K091045)Body Clock Health Care, Ltd.2009-12-18
RESTORATION ADM SYSTEM X3 ACETABULAR (K093644)Howmedica Osteonics Corp.2009-12-18
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 (K090921)Beiersdorf, Inc.2009-12-18
SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON (K090806)Safilens, S.R.L.2009-12-18
DYNAREX STERILE LUBRICATING JELLY (K092488)Dynarex Corporation2009-12-18
ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 (K093050)Arrow Intl., Inc.2009-12-18
ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE (K092044)Orthocor Medical2009-12-18
FLUID-FILLED TEETHER (K092910)Qualiman Industrial Co., Ltd.2009-12-18
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018 (K092483)C.R. Bard, Inc.2009-12-18
GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM (K092546)Gmdasz Manufacturing Co., Ltd.2009-12-18
STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER (K093001)Diagnostica Stago, Incorporated2009-12-18
ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT (K093113)Institut Straumann AG2009-12-18
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) (K090515)Maquet Cardiopulmonary, AG2009-12-18
ARP RX100 (K093259)Arp Manufacturing, Inc.2009-12-17
DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES (K092557)Harvard Medical Devices , Ltd.2009-12-17
LAC-MAC INNERBLOC LR SURGICAL GOWNS (K092344)Lac Mac, Ltd.2009-12-17
SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR (K093428)Smith & Nephew Endoscopy, Inc.2009-12-17
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Every clearance here is in the API, with alerts when new ones post.