Atlas FDA

2006

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

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RecordFirmDate
DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K060949)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-05-04
LEGION COBALT CHROME REVISION KNEE SYSTEM (K060742)Smith & Nephew, Inc.2006-05-03
PIEZOTOME (K060275)Satelec2006-05-03
SPEECHLINK 100 TYPE 1053 (K061104)Gn Otometrics A/S2006-05-03
EG-3670URK (K061068)Pentax Medical Company2006-05-03
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH (K060585)Roche Diagnostics Corp.2006-05-03
GE LOGIQ P5 AND A5 (K060993)General Electric Co.2006-05-03
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM (K060287)W&H Dentalwerk Buermoos GmbH2006-05-03
SPY INTRAOPERATIVE IMAGING SYSTEM (K060867)Novadaq Technologies, Inc.2006-05-03
ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 (K060353)Acro Biotech, LLC2006-05-03
SENSOR WALK (K052771)Otto Bock Healthcare LP2006-05-03
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER (K052639)Biomet Manufacturing, Inc.2006-05-03
TOTAL BILIRUBIN (K060574)Abbott Laboratories2006-05-03
MEDELA SWING BREAST PUMP (K053052)Medela AG2006-05-02
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS (K061009)Onset Medical Corporation2006-05-02
KIMBERLY-CLARK PROCEDURE GOWN (K052824)Kimberly-Clark Corp.2006-05-02
FIDIS DSDNA (K060380)Biomedical Diagnostics (Bmd) SA2006-05-02
SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 (K060273)Sleepnet Corporation2006-05-02
BIFIX QM (K060894)Voco GmbH2006-05-02
HEMOSIL PT-FIBRINOGEN HS PLUS (K060931)Instrumentation Laboratory CO2006-05-02
COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA (K060799)Cosman Medical, Inc.2006-05-02
CMA CEREBRAL TISSUE MONITORING SYSTEM (K060554)Cma Microdialysis AB2006-05-02
G.USBAMP (K060803)G.Tec Medical Engineering GmbH2006-05-02
EAGLEVISION GELLANSERTS, MODEL REF 0040 (K053333)Eagle Vision, Inc.2006-05-02
PYLO-PLUS (K052708)Arj Medical, Inc.2006-05-01
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING (K060073)Shen Wei (Usa), Inc.2006-05-01
NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT (K060728)Novabone Products, LLC2006-05-01
JETSTREAM WORKSPACE (K061029)Adac Laboratories2006-05-01
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED (K060771)Kossan Latex Industries(M)Sdn Bhd2006-05-01
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED (K060784)Ever Light Plastic Products Co., Ltd.2006-05-01
15-INCH (38CM) COLOR LCD MONITOR CDL1566A (K060961)Totoku Electric Co., Ltd.2006-05-01
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 (K060633)Siemens Medical Solutions USA, Inc.2006-05-01
PIEZOTOME (K060274)Satelec2006-05-01
ANTHOGYR CONTRA ANGLES AND HANDPIECES (K060317)Est. Anthogyr2006-04-28
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K060904)Rex Medical, L.P.2006-04-28
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (K060345)Nova Biomedical Corp.2006-04-28
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 (K060336)Orthosoft, Inc.2006-04-28
PREMISE FLOWABLE (K060472)Kerr Corporation2006-04-28
ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT (K060887)AngioDynamics, Inc.2006-04-28
SYNGO US WORKPLACE (K060992)Siemens Medical Solutions2006-04-28
MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) (K060743)Safety Syringes, Inc.2006-04-28
POROUS TITANIUM ACETABULAR SHELLS (K052996)Biomet Manufacturing Corp2006-04-28
PRESEP OLIGON OXIMETRY CATHETERS (K060093)Edwards Lifesciences, LLC2006-04-28
V-505 INFA WARMER (K060461)Atom Medical, Inc.2006-04-28
DSI PINS AND WIRES (K060654)Delta Surgical Instruments, Inc.2006-04-28
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT (K060935)Beckman Coulter, Inc.2006-04-28
MULTIDIRECTIONAL THREADED PEG (K060864)Hand Innovations, LLC2006-04-28
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS (K060577)Ortho Development Corp.2006-04-28
MICRUS GUIDE WIRE, WATUSI 0.014 (K053265)Micrus Endovascular Corporation2006-04-28
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 (K060139)Diagnostic Chemicals , Ltd.2006-04-28
PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS (K060866)Carmel Pharma Ab.2006-04-28
IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 (K060929)Diagnostic Products Corporation2006-04-28
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP (K060222)Gemore Technology Co, Ltd.2006-04-28
SPECTRAGENICS ATS-1 (K060567)Spectragenics, Inc.2006-04-28
CONSENSUS ACETABULAR SHELL SYSTEM (K060635)Hayes Medical, Inc.2006-04-28
PLANAR DOME EX LINE MODEL DOME E2C (K061018)Planar Systems, Inc.2006-04-28
ENTAKE STANDARD AND SAFETY PEG SYSTEM (K061021)Conmedcorp2006-04-28
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS (K060761)Akers Biosciences, Inc.2006-04-28
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS (K060370)Zimmer, Inc.2006-04-28
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE (K060778)Ever Light Plastic Products Co., Ltd.2006-04-28
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY (K060339)Tyco Healthcare/Kendall2006-04-28
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION (K060706)Liberty Healthcare Group, Inc.2006-04-28
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K060147)Hongye Plastic Products Co., Ltd.2006-04-28
STRYKER SCOPE/INSTRUMENT HOLDER (K060085)Stryker Endoscopy2006-04-27
VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 (K060441)Vident2006-04-27
INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE (K060413)Intact Medical Corporation2006-04-27
STAXX XD SYSTEM (K052670)Spine Wave, Inc.2006-04-27
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (K053078)Ergoline GmbH2006-04-27
VELSCOPE (K060920)Led Medical Diagnostics, Inc.2006-04-27
TULIP DISPOSABLE CANNULAS (K060089)Cell Bio-Systems, Inc.2006-04-27
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 (K051419)Inditherm Medical2006-04-27
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) (K060753)Siam Sempermed Corp., Ltd.2006-04-27
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA (K060390)Galil Medical , Ltd.2006-04-27
VIVAWAVE MICROWAVE ABLATION SYSTEM (K053535)Valleylab2006-04-27
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F (K053491)Penumbra, Inc.2006-04-27
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX (K060877)Cordis Corp.2006-04-27
AMPLATZER NOODLEWIRE GUIDEWIRE (K053187)Aga Medical Corp.2006-04-27
COOLGARD 3000 (K060308)Alsius Corp.2006-04-26
ASP TITANIUM (K060392)Sedatelec2006-04-26
PHICAL TEST (DEN060001)Genova Diagnostics2006-04-26
DR DISPOSABLE PROPHY ANGLE MODEL H310 (K060377)Dental Resources2006-04-26
PREFTEST PROFESSIONAL SUITE (K052929)Limestone Technologies, Inc.2006-04-26
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS (K060710)Zimmer, Inc.2006-04-26
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM (K060990)Endius, Inc.2006-04-26
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) (K060447)Becton, Dickinson & CO2006-04-26
DRI-STAT ACID PHOSPHATASE REAGENT (K053612)Beckman Coulter, Inc.2006-04-26
ECP HEALTH SYSTEM, MODEL 2005 (K052611)Ecp Health, Inc.2006-04-26
C. DIFF QUIK CHEK (K053572)Techlab, Inc.2006-04-26
PHYSIOGLOVE ES (K050674)Commwell , Ltd.2006-04-25
LESIONPOINT RF CANNULA (K053415)Cosman Medical, Inc.2006-04-25
NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM (K060717)Conmed Integrated Systems (Cmis)2006-04-25
SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24 (K060376)Simpler Implant, Inc.2006-04-25
THROMCAT THROMBECTOMY CATHETER SYSTEM (K060016)Kensey Nash Corp.2006-04-25
MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310 (K060845)Eizo Nanao Corporation2006-04-25
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER (K060660)Edwards Lifesciences, LLC2006-04-25
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 (K053263)Cardionet, Inc.2006-04-25
GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE (K060195)Gambro Renal Products2006-04-24
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM (K060807)Biotronik, Inc.2006-04-24
IVA (MXA II SOFTWARE OPTION) (K060111)Hologic, Inc.2006-04-24
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 (K060140)Diagnostic Chemicals , Ltd.2006-04-24
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