Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A (K100399)Well-Life Healthcare Limited2010-06-25
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS (K101431)C.R. Bard, Inc.2010-06-25
REPROCESSED PINS (K100707)Sterilmed, Inc.2010-06-25
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE (K100214)Medtronic Sofamor Danek2010-06-25
CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 (K101018)Cardica, Inc.2010-06-25
MYOSCIENCE CRYO-TOUCH (K100447)Myoscience, Inc.2010-06-25
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (K083878)R2 Diagnostics, Inc.2010-06-25
SURGIMESH XD (K092233)Aspide Medical2010-06-25
MYLABTWICE, MODEL 6200 (K100931)Esaote, S.p.A.2010-06-25
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (K101639)Card Guard Scientific Survival , Ltd.2010-06-25
OCTO (K100045)Dalim Surgnet Corporation2010-06-25
PR CREAM (K093159)Prugen IP Holdings, Inc.2010-06-24
VASOVAPOR (K101320)Lexion Medical, LLC2010-06-24
BD DIRECTIGEN EX FLU A+B (K101461)Becton, Dickinson and Company2010-06-24
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D (K093357)Diamond Diagnostics, Inc.2010-06-24
DARCO HEADED CANNULATED SCREW (K100359)Wrightmedicaltechnologyinc2010-06-24
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX (K100665)Needle Tech Products, Inc.2010-06-24
ECHOBRIGHT (K093662)Life-Tech, Inc.2010-06-24
STERN'S S250 NORDAM (K092917)Cefla S.C.2010-06-24
CONSENSUS REVISION KNEE SYSTEM (K100542)Consensus Orthopedics, Inc.2010-06-24
AEDIS(TM) (K100902)Embed Technology, LLC2010-06-24
PRUCLAIR NONSTEROIDAL CREAM (K093156)Prugen IP Holdings, Inc.2010-06-24
MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS (K093643)Nobel Biocare AB2010-06-24
KAI SPOT MODEL KMS 200 (K100773)Kai Medical, Inc.2010-06-23
MIRADA XD (K101228)Mirada Medical, Ltd.2010-06-23
8 CHANNEL CARDIAC PHASED ARRAY COIL (K101492)Ge Healthcare Coils (Usa Instruments, Inc.)2010-06-23
UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS (K093078)Bonutti Research, Inc.2010-06-23
ENDOFORM DENTAL TEMPLATE (K101546)Mesynthes, Ltd.2010-06-23
B-GENIN AND R-GENIN (K091912)Berkeley Advanced Biomaterials, Inc.2010-06-23
NUVASIVE VUEPOINT OCT SYSTEM (K093319)Nuvasive, Inc.2010-06-23
SLEEVE WITH ZIPLOOP FIXATION DEVICES (K101063)Biomet Sports Medicine2010-06-23
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM (K100438)Ebi, L.P.2010-06-23
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET (K101481)Biomers Products, LLC2010-06-23
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH (K101116)Abbott Vascular-Cardiac Therapies2010-06-23
ACL TIGHTROPE (K100652)Arthrex, Inc.2010-06-23
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM (K100409)Biomet Spine (Aka Ebi, LLC)2010-06-23
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 (K100403)Masimo Corporation2010-06-23
CEDARA WEBACCESS, MODEL: 2.4 (K092915)Cedara Software Corp.2010-06-23
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C (K100798)Medrad, Inc.2010-06-23
BACK-TEK (K101227)York Biomedical, Inc.2010-06-23
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 (K093707)U&I Corp.2010-06-23
MAM TWISTER (K092781)Mam International AG2010-06-23
CORONIS FUSION 10MP, MODEL MDCG-10130 (K093197)Barco N.V.2010-06-23
MAC-MOBILE AQUATIC CHAIR (K101217)Rehamed Intl., LLC2010-06-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K101137)Hongze Plastic Technology Co., Ltd.2010-06-22
TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS (K090081)Talladium Espana, SL2010-06-22
TINA-QUANT FERRITIN GEN. 4 (K100538)Roche Diagnostics2010-06-22
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, (K101345)Biosense Webster, Inc.2010-06-22
ZQUIET MOUTHPIECE (K093407)Sleeping Well, LLC2010-06-22
MLS-AC DERMA SCANNER (K101430)Erchonia Corporation2010-06-22
UNICEM HM (K100908)3M Espe AG Dental Products2010-06-22
DUAL LUER LOCK CAP, MODEL 2C6250 (K101385)Baxter Healthcare Corp2010-06-22
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD (K101451)Omni Life Science, Inc.2010-06-22
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL (K101564)Centers for Disease Control and Prevention2010-06-22
AFFIITY CP CENTRIFUGAL BLOOD PUMP (K100631)Medtronic, Inc.2010-06-22
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM (K101074)Medtronic Sofamor Danek USA, Inc.2010-06-22
ANTI-HAV IGM (K093955)Roche Diagnostics2010-06-22
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 (K101138)Biosense Webster, Inc.2010-06-22
STRYKER BIPOLAR FORCEPS (K093108)Stryker Leibinger GmbH & Co KG2010-06-22
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES (K092874)Quality Gallant Sdn. Bhd.2010-06-22
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS (K100388)Medical Illumination International, Inc.2010-06-22
PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 (K100495)Philips Electronics UK Limited2010-06-22
QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) (K100497)N.M.B. Medical Applications, Ltd.2010-06-21
NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX (K101080)Egon Faulhaber Surgical Instruments Pinzetten2010-06-21
OPUS SPEEDSCREW SYSTEM (K101448)Arthrocare Corp.2010-06-21
OBSIDIAN CERAMIC BLOCKS (K100781)Prismatik Dentalcraft, Inc.2010-06-21
FIAB SPA, MODELS F7244, F7233, F7234, F7277 (K100333)Fiab Spa2010-06-21
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K100685)Alphatec Spine, Inc.2010-06-18
PUMA MODEL VERSION 1.0 (K100801)Prowess, Inc.2010-06-18
CARTO XP EP NAVIGATION SYSTEM, VERSION 10 (K093566)Biosense Webster, Inc.2010-06-18
MOTIVATION KNEE SYSTEM (K100900)Encore Medical L.P.2010-06-18
LASSO NAV CATHETER (K093376)Biosense Webster, Inc.2010-06-18
INTELLIVUE PATIENT MONITOR (K101449)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010-06-18
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO (K093623)Instrumentation Laboratory CO2010-06-18
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 (K101440)Generic Medical Devices, Inc.2010-06-18
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 (K100638)Depuy Mitek, A Johnson & Johnson Company2010-06-18
DRYODINE CADEXOMER-IODINE GEL (K093320)Collegium Pharmaceutical Incorporated2010-06-18
COMPRESS ANTI-ROTATION SPINDLES (K101475)Biomet Manufacturing Corp2010-06-18
PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) (K091786)Pulsion Medical Systems AG2010-06-18
BF-NAVI (K093810)Kgt, Inc.2010-06-18
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) (K093335)La Glove (M) Sdn. Bhd.2010-06-18
ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 (K101115)Mortara Instrument, Inc.2010-06-18
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 (K092052)Bionime Corporation2010-06-18
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') (K093109)Novo Nordisk, Inc.2010-06-18
MULTIFUNCTIONAL LINEAR PEN (K100501)AtriCure, Inc.2010-06-18
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 (K092938)App Pharmaceuticals, LLC2010-06-18
HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 (K101111)Barrx Medical, Inc.2010-06-18
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K101362)Hebei Handform Plastic Products Co., Ltd.2010-06-17
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS (K101017)AngioDynamics, Inc.2010-06-17
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS (K093466)Hitachi Medical Systems America, Inc.2010-06-17
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (K100539)Preventive Technologies, Inc.2010-06-17
T2 GREATER TROCHANTER NAIL (K101438)Howmedica Osteonics Corp.2010-06-17
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 (K101259)Taidoc Technology Corporation2010-06-17
CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE (K101523)Devon Medical, Inc.2010-06-17
FIDUCIAL MARKERS (K101131)Cosman Medical, Inc.2010-06-17
O-ARM IMAGING SYSTEM (K092564)Medtronic Navigation, Inc. (Littleton)2010-06-17
OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE (K093395)Olympus Medical Systems Corporation2010-06-17
COAXIAL INTRODUCER SET (K101399)Martech Medical Products2010-06-17
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E (K093619)Cook Ireland, Ltd.2010-06-17
PATCHASSIST (K101218)Polytouch Medical, Ltd.2010-06-17
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Every clearance here is in the API, with alerts when new ones post.