Atlas FDA

2006

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

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RecordFirmDate
THERATRON EQUINOX, MODELS 80 CM AND 100 CM (K053485)Mds Nordion, Inc.2006-03-09
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 (K051839)Abbott Diabetes Care, Inc.2006-03-09
THE EMIT 2000 TACROLIMUS CALIBRATORS (K060371)Dade Behring, Inc.2006-03-09
LIBERTY GLUCOSE CONTROL SOLUTION (K060481)Liberty Healthcare Group, Inc.2006-03-09
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (K053553)Polymedco, Inc.2006-03-09
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE (K053194)Biosense Webster, Inc.2006-03-09
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO (K060338)Lumenis, Inc.2006-03-09
ACCUREX GLUCOSE TEST STRIP (K052207)Incline Medical, LLC2006-03-09
BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML (K060214)Becton, Dickinson & CO2006-03-09
QUICKCAT EXTRACTION CATHETER (K060092)Kensey Nash Corp.2006-03-09
VITREA2 VERSION 3.8.1 (K060378)Vital Images, Inc.2006-03-09
MDXNET (K060035)Cybermdx, Inc.2006-03-09
LYSUS INFUSION SYSTEM (K060422)Ekos Corp.2006-03-09
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS (K053645)Arizant Healthcare, Inc.2006-03-09
DIMENSION IRON CALIBRATOR (K060266)Dade Behring, Inc.2006-03-09
AZE VIRTUALPLACE (K060453)Aze, Ltd.2006-03-09
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 (K060426)Liberty Healthcare Group, Inc.2006-03-09
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (K053488)Conformis, Inc.2006-03-09
ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER (K060023)AngioDynamics, Inc.2006-03-09
DP240 240 HOUR DOPPLER PROBE (K052989)Deltex Medical2006-03-08
GSS PEDICLE SCREW SYSTEM (K053573)GS Medical Co., Ltd.2006-03-08
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM (K060057)Ev3, Inc.2006-03-08
BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 (K060337)Sauter AG2006-03-08
COLLOSS E BONE VOID FILLER (K051047)Ossacur AG2006-03-08
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 (K050709)Wallac OY2006-03-08
AVANTICARE, MODEL SA4021 (K060068)Lerado China Limited2006-03-08
ACTIVECARE ++ SYSTEM (K060146)Medical Compression Systems (Dbn) , Ltd.2006-03-08
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 (K053217)St Jude Medical2006-03-08
RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A (K060077)Real Tone Technology Corp.2006-03-08
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) (K060264)Dade Behring, Inc.2006-03-08
WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100 (K060251)Well Home Health Products Co.2006-03-08
THEROX INFUSION CATHETER, MODEL INCA-1 (K052637)Therox, Inc.2006-03-08
TECHDEVICE GUIDEWIRE (K053251)Techdevice Corporation2006-03-08
CSS CANNULATED SCREW SYSTEM (K060428)Orthohelix Surgical Designs, Inc.2006-03-07
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM (K052202)Siemens Medical Solutions USA, Inc.2006-03-07
COMPE1 1 -PLY SURGICAL GOWNS (K060181)Standard Textile Co., Inc.2006-03-07
MERITS MODEL E SERIES LIFT CHAIRS (K060212)Merits Health Products Co., Ltd.2006-03-07
PROVISIONAL INLAY/ONLAY KIT (K052800)Dmg USA, Inc.2006-03-07
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS (K060103)Albert Browne , Ltd.2006-03-07
AIM ACCURACY IN MARKING SYSTEM (K053463)Georgene Austria2006-03-07
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE (K053442)Regent Medical Americas, LLC2006-03-07
NUVANCE* FACIAL REJUVENATION SYSTEM (K052953)ETHICON, Inc.2006-03-06
ALLOMATRIX CUSTOM (K053319)Wrightmedicaltechnologyinc2006-03-06
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER (K060224)Cook Incorporated2006-03-06
XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM (K060361)Stryker Spine2006-03-06
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER (K051617)Novabone Products, LLC2006-03-06
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM (K060009)Abbott Spine, Inc.2006-03-06
ATHROCARE TOPAZ ARTHROWANDS (K053567)Arthrocare Corp.2006-03-06
RX HERCULINK ELITE BILIARY STENT SYSTEM (K053454)Guidant Corporation2006-03-06
EBI ANTERIOR CERVICAL PLATE SYSTEM (K060379)Ebi, L.P.2006-03-06
ACUITY STEERABLE STYLET ACCESSORY (K053019)Guidant Corporation2006-03-03
DOCTOR'S NIGHTGUARD (K053580)Dental Concepts, LLC2006-03-03
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (K060277)Boehringer Laboratories2006-03-03
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 (K053475)Refractec, Inc.2006-03-03
FENIIIIIIX COLORATION KIT (K060086)Dental Arte, Inc.2006-03-03
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE (K053450)Atlantis Components, Inc.2006-03-03
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR (K053531)Dade Behring, Inc.2006-03-03
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 (K053564)Penlon Limited2006-03-03
KODAK MODELS 2100 AND 2200 (K060292)Kodak-Trophy2006-03-03
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER (K053430)Medtronic Xomed, Inc.2006-03-03
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM (K052623)Medtronic Navigation, Inc.2006-03-02
VYGON LATEX FREE BIONECTOR (K052881)Vygon Corp.2006-03-02
FIDIS VASCULITIS, MODEL MX007 (K053012)Biomedical Diagnostics (Bmd) SA2006-03-02
LC SPRINT NEBULIZER (K060399)Pari Innovative Manufacturers, Inc.2006-03-02
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM (K060209)Tornier2006-03-02
PALOMAR LUXIR FRACTIONAL HANDPIECE (K060069)Palomar Medical Technologies, Inc.2006-03-02
INNOCOR (K051907)Innovision A/S2006-03-02
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN (K050975)Nano-Ditech Co.2006-03-02
COLORBITE (K053619)Zhermack S.P.A.2006-03-01
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM (K053087)Biotex, Inc.2006-03-01
INTEGRA (K053640)Direx Systems Corp.2006-03-01
CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF (K053039)Clinton Electronics Corp.2006-03-01
STRYKER INJECTABLE CEMENT (K060061)Stryker Corp.2006-03-01
U2 TOTAL KNEE SYSTEM (K051640)United Orthopedic Corp.2006-03-01
MYSET PREGNANCY TEST (K053138)Ani Biotech OY2006-03-01
EASYMATE BLOOD GLUCOSE MONITORING SYSTEM (K053312)Bioptik Technology, Inc.2006-03-01
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 (K060420)Scantibodies Laboratory, Inc.2006-03-01
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM (K050828)Church & Dwight Co., Inc.2006-02-28
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR (K052450)Kodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-02-28
PROFILE MULTI-PLATFORM SYSTEM (K060033)Sciton, Inc2006-02-28
CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT (K060400)Medtronic, Inc.2006-02-28
CURAY CUSTOM SEED ARRAY (K053595)Biolucent, Inc.2006-02-28
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K053609)Edwards Lifesciences, LLC2006-02-28
CRYOCARE CS SURGICAL SYSTEM (K060279)Endocare, Inc.2006-02-28
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE (K060034)Nipro Medical Corporation2006-02-28
DRLOCK DISTAL RADIUS VOLAR SYSTEM (K053182)Orthohelix Surgical Designs, Inc.2006-02-27
LEONE IMPLANT SYSTEM (K050586)Leone S.P.A.2006-02-27
SLACTIVE IMPLANTS (K053088)Institut Straumann AG2006-02-27
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (K060256)Beckman Coulter, Inc.2006-02-27
GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES (K052665)Granton Medical , Ltd.2006-02-27
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (K060348)Scantibodies Laboratory, Inc.2006-02-27
MIIG SR (K060011)Wrightmedicaltechnologyinc2006-02-27
TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS (K053340)Zimmer Trabecular2006-02-27
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE (K060090)Dade Behring, Inc.2006-02-27
AEROECLIPSE II BREATH ACTUATED NEBULIZER (K053605)Trudell Medical Intl.2006-02-27
SHOULDER FIXATION SYSTEM (K060290)Hand Innovations, LLC2006-02-27
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 (K060097)KLS-Martin L.P.2006-02-27
PREFORMANCE TEMPORARY CYLINDER (K060291)Implant Innovations, Inc.2006-02-27
DERMASTREAM (K060046)Enzysurge , Ltd.2006-02-27
TECHDEVICE OCCLUSION BALLOON CATHETER (K051137)Techdevice Corporation2006-02-24
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Every clearance here is in the API, with alerts when new ones post.