Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING (K063173)Advanced Medical Solutions Limited2006-11-03
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL (K062455)Philips Medical Systems2006-11-03
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES (K062454)Siemens Medi Cal Solutions, Inc.2006-11-03
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION (K063184)Toshiba America Medical Systems, In.C2006-11-03
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA (K062597)Terumo Cardiovascular Systems Corp.2006-11-03
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) (K062671)Kendall2006-11-03
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (K062999)Hospira, Inc.2006-11-03
POLY-CHEM CREATININE (K061944)Polymedco, Inc.2006-11-03
SONARA; SONARA/TEK (K060421)Viasys Healthcare, Inc.2006-11-03
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX (K063117)Medtronic Neurosurgery2006-11-03
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE (K061233)Pt Mahakarya Inti Buana2006-11-03
GOLDEN LITEWAY (K063162)Golden Technologies, Inc.2006-11-02
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (K062642)Rf Surgical Systems, Inc.2006-11-02
HEPATOSTAT SET, MODEL 760X (K061796)Vygon Corp.2006-11-02
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 (K063130)Toshibamedical Systems Corporation2006-11-02
GRANDIO FLOW TRY-IN (K062343)Voco GmbH2006-11-02
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU (K062740)Jindell Medical Instruments Co., Ltd.2006-11-02
MODIFICATION TO EXPEDIUM SPINE SYSTEM (K062174)Depuy Spine, Inc.2006-11-02
PRISM VIEW, MODEL (K063031)Kyron Clinical Imaging, Inc.2006-11-02
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 (K062917)Wear Safe Malaysia Sdn. Bhd.2006-11-02
GAS MODULE SE, MODEL 0998-00-0481-02 (K062754)Datascope Corp.2006-11-02
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM (K063039)Imaging Dynamics Company , Ltd.2006-11-02
GE LOGIQ WORKS (K063006)General Electric Co.2006-11-02
US SYSTEM (K062030)Osstem Implant Co., Ltd.2006-11-02
HEM-O-LOK LIGATION CLIP (K062914)Teleflex Medical2006-11-02
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER (K061288)United States Surgical, A Division of Tyco Healthc2006-11-02
MEDLINE SURGICAL SPONGE SCANNER (K061316)Medline Industries, Inc.2006-11-02
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 (K063029)E-Z-Em, Inc.2006-11-02
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 (K060987)Cp Medical2006-11-02
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS (K063075)Power Medical Interventions, Inc.2006-11-02
MALE REMEEX SYSTEM (K062341)Specialities Remeex International, S.L.2006-11-02
LITHOGOLD (K062081)Tissue Regeneration Technologies, Inc.2006-11-02
ADHESIVE DC ACTIVATOR (K062713)Ivoclar Vivadent, Inc.2006-11-02
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 (K062323)Smiths Medical MD, Inc.2006-11-01
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) (K063099)Dade Behring, Inc.2006-11-01
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ (K061830)Nova Biomedical Corp.2006-11-01
KOWA VX-10I (K062021)Kowa Co. , Ltd.2006-11-01
ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON (K061639)Axon Systems, Inc.2006-11-01
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062816)Trek Diagnostic Systems, Inc.2006-11-01
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML (K063101)Dade Behring, Inc.2006-11-01
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) (K062614)Johnson & Johnson Vision Care, Inc.2006-11-01
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES (K062548)Contamac, Ltd.2006-11-01
SS SYSTEM (K062051)Osstem Implant Co., Ltd.2006-11-01
MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT (K063033)Orthopedic Sciences, Inc.2006-11-01
PRIMACONNEX CERAMIC ABUTMENTS (K062876)Lifecore Biomedical, Inc.2006-11-01
ALTRA PRESS-FIT HIP SYSTEM (K063002)Biomet Manufacturing Corp2006-10-31
PATIENT CONTOURED MESH (PCM) (K062570)KLS-Martin L.P.2006-10-31
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 (K062743)Electronic Business Machine Co., Ltd. (Ebm)2006-10-31
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM (K062863)Osteomed LP2006-10-31
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS (K061925)Arthrex, Inc.2006-10-31
IMT.LAB SOFTWARE (K062598)Esaote Europe B.V.2006-10-31
CHRONOS VISION EYE TRACKING DEVICE (C-ETD) (K062015)Chronos Vision2006-10-31
ANATOMICAL SHOULDER FRACTURE SYSTEM (K062029)Zimmer GmbH2006-10-31
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT (K062995)Biomet Manufacturing Corp2006-10-31
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER (K062476)Ceragem International, Inc.2006-10-31
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT (K063191)Heidelberg Engineering2006-10-31
SMARTLIPO ND:YAG LASER (K062321)Cynosure, Inc.2006-10-31
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM (K062861)Ascension Orthopedics, Inc.2006-10-31
MAGPRO, MODEL R30 (K061645)Tonica Elektronik A/S2006-10-31
OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 (K062472)Source-Ray, Inc.2006-10-31
OXYLOG 3000 (K062267)Drager Medical B.V.2006-10-31
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 (K061922)Sentech Korea Corp.2006-10-30
QUANTIMETRIX NICOSURE COTININE URINE CONTROL (K062942)Quantimetrix Corp.2006-10-30
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K062967)Accuray, Inc.2006-10-30
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS (K063024)Lin-Zhi International, Inc.2006-10-30
MEDLOG, MODEL 1-0-10 (K060756)Bmc Gesellschaft Fur Medizintechnik Mbh2006-10-30
GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM (K061234)Glucoplus, Inc.2006-10-30
SUPERCATH V (K052267)Togo Medikit Co., Ltd.2006-10-27
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (K062438)Cook Ob/Gyn2006-10-27
GYNESONICS EC6 TRANSDUCER (K061153)Gynesonics, Inc.2006-10-27
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED (K062778)Wear Safe Malaysia Sdn. Bhd.2006-10-27
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES (K062016)Choice Smart Health Care Co. , Ltd.2006-10-27
TUTU 7, MODEL IV-T22 (K062735)Invisible Technology Co., Ltd.2006-10-27
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A (K062860)Neusoft Medical Systems Co., Ltd.2006-10-27
INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 (K062068)Intelwave, LLC2006-10-27
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) (K063065)Dade Behring, Inc.2006-10-27
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI (K062376)Rf Systems Lab.2006-10-27
ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 (K062716)Eco-Rx, Inc.2006-10-27
VISAGE PACS/CS, RELEASE VERSION 4.1 (K062490)Mercury Computer Systems, Inc.2006-10-27
VISTADENT OC - VERSION 4 (K060836)Dentsply Intl., Inc.2006-10-27
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE (K060889)Pentron Clinical Technologies2006-10-27
AMICAS VISION SERIES PACS, MODEL 4.3 (K062477)Amicas, Inc.2006-10-27
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 (K062653)Parnell Pharmaceuticals, Inc.2006-10-27
EP-WORKMATE (K063113)Ep Medsystems2006-10-27
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES (K062010)Global Treasure Industries , Ltd.2006-10-27
3DNET SUITE (K063107)Biotronics3D, Ltd.2006-10-27
MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) (K063053)Dade Behring, Inc.2006-10-26
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (K062699)B.Braun Medical, Inc.2006-10-26
CST61 HIGH SPEED TURBINE HANDPIECE (K063110)Shanghai Dental Instrument Factory2006-10-26
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF (K062471)Misonix, Inc.2006-10-26
OSTEOBOOST-BMA (K062260)Orthos Limited2006-10-26
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) (K063064)Dade Behring, Inc.2006-10-26
NEOTRACT ANCHOR (K061700)Neotract, Inc.2006-10-26
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) (K062375)Dade Behring, Inc.2006-10-26
STRYKER ARIA PNEUMATIC SYSTEM (K061725)Stryker Instruments2006-10-26
MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F (K062887)Bard Peripheral Vascular2006-10-26
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062783)Trek Diagnostic Systems, Inc.2006-10-26
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 (K052055)Smisson-Cartledge Biomedical, LLC2006-10-26
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM (K061899)Advanced Sterilization Products2006-10-26
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM (K062700)B.Braun Medical, Inc.2006-10-26
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Every clearance here is in the API, with alerts when new ones post.