Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
EZ-MIO STERNAL (K063567)Vidacare Corporation2007-01-26
TECO MICROALBUMIN 2-1 COMBO STRIPS (K061419)Teco Diagnostics2007-01-26
TISSUE SITE MARKING SYSTEM (K062528)Suros Surgical Systems, Inc.2007-01-26
SENTINEL (K062397)Del Mar Reynolds Medical, Ltd.2007-01-25
MICROTEK MEDICAL SURGICAL GOWN/TOGA (K062899)Microtek Medical, Inc.2007-01-25
V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 (K063590)Kci USA, Inc.2007-01-25
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS (K062666)Ortho Development Corp.2007-01-25
INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC (K070155)Osseo Scientific, LLC2007-01-25
FEMORAL INTRAFIX SCREW AND SHEATH (K063577)Johnson & Johnson Company2007-01-25
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER (K070010)Z-Medica Corporation2007-01-25
MODIFICATION TO HIPSTAR FEMORAL STEM (K063822)Stryker Orthopaedics2007-01-25
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K (K052973)Baxter Healthcare Corp2007-01-25
PILOT SPINAL SYSTEM (K063601)Life Spine2007-01-25
DERMATHERAPY, MODEL 22216 (K061242)Precision Fabrics Group, Inc.2007-01-25
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (K063664)Gen-Probe, Inc.2007-01-25
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 (K063450)Smiths Medical Asd, Inc.2007-01-25
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER (K070071)Omniguide, Inc.2007-01-25
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER (K063377)C.R. Bard, Inc.2007-01-25
DIOMED DELTA 25 (K063828)Diomed, Ltd.2007-01-25
PHASE 3, MODEL DT-1 (K062099)Datrend Systems, Inc.2007-01-25
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER (K063586)Moor Instruments, Ltd.2007-01-25
ACTIM PROM AND CONTROLS (K061886)Medix Biochemica2007-01-25
GEODESIC EEG SYSTEM 300 (K063797)Electrical Geodesics, Incorporated2007-01-25
SHARPS CONTAINER, MODEL 039-413 (K063666)Biodex Medical Systems, Inc.2007-01-25
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING (K061554)Molnlycke Health Care2007-01-25
REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM (K063834)Hoya Conbio, Inc.2007-01-25
CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 (K062082)Conmed Corporation2007-01-25
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM (K062765)Nuvasive, Inc.2007-01-24
MODIFICATION TO EASYSPINE SYSTEM (K063794)Ldr Spine USA2007-01-24
SOMNOSCREEN (K060708)Somnomedics GmbH & Co. KG2007-01-24
INTELEPACS (K070080)Intelerad Medical Systems, Inc.2007-01-24
TOPACS (K063294)Radiological Specialists, Inc.2007-01-24
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (K063821)Nova Biomedical Corp.2007-01-24
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE (K070093)Ceremed , Inc.2007-01-24
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H (K063322)Dade Behring, Inc.2007-01-24
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT (K063235)Cytori Therapeutics, Inc.2007-01-24
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY (K063251)Zimmer, Inc.2007-01-24
MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 (K063774)Concentric Medical, Inc.2007-01-24
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) (K063524)Hl Rubber Industries Sdn Bhd2007-01-23
CF-1 (K063717)Canon, Inc.2007-01-23
DEN TEK NIGHTGUARD (K063483)Den Tek Oral Care, Inc.2007-01-23
LANDLEX, MODEL S403X (K063196)Besteam Technology, Inc.2007-01-23
POWDERED VINYL PATIENT EXAMINATION GLOVE (K070035)Super Safe Plastic Products Co., Ltd.2007-01-23
DUET SYSTEM (K061602)Bioview , Ltd.2007-01-23
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 (K060818)Biokit, S.A.2007-01-23
INION CPS/OTPS FREEDOMPLATE (K063410)Inion , Ltd.2007-01-23
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN (K063508)Dade Behring, Inc.2007-01-23
IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) (K063475)Imc-Heart Way LLC2007-01-23
EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD (K061414)Pacific Consolidated Industries, LLC2007-01-22
COR ANALYZER 1, VERSION 1.4 (K063548)Rcadia Medical Imaging , Ltd.2007-01-22
THERMOGARD THERMAL REGULATION SYSTEM (K063829)Alsius Corp.2007-01-22
GLASS LOSS OF RESISTANCE SYRINGE (K063018)Busse Hospital Disposables, Inc.2007-01-22
TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM (K063434)Radiometer Basel AG2007-01-22
MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS (K063439)Mtd, Inc.2007-01-22
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (K063451)Gen-Probe, Inc.2007-01-22
MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE (K063487)Merete Medical GmbH2007-01-22
TWINKY STAR NF (K063604)Voco GmbH2007-01-22
TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT (K063423)Howmedica Osteonics2007-01-22
SELECT TENS, MODEL 4600S (K061650)Empi2007-01-22
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH (K063351)Dade Behring, Inc.2007-01-22
BREAS ISLEEP 20I (K063476)Breas Medical AB2007-01-22
EUKARE (K062892)Eumed Biotechnology Co., Ltd.2007-01-22
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) (K062998)Biomet Manufacturing Corp2007-01-19
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K070006)Zibo Hengde Plastic & Rubber Products Co., Ltd.2007-01-19
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (K062503)Catachem, Inc.2007-01-19
LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE (K061670)William Cook Europe Aps2007-01-19
ACE BOND SE (K063780)Bisco, Inc.2007-01-19
RADIFOCUS GLIDEWIRE ADVANTAGE (K063372)Terumo Medical Corp.2007-01-19
MODIFIED MERCI RETRIEVER, MODEL 90050 (K062046)Concentric Medical, Inc.2007-01-19
SPIDERFX EMBOLIC PROTECTION DEVICE (K063785)Ev3, Inc.2007-01-19
LINGLOCK (K061042)Sybron Dental Specialties2007-01-19
MOORLDLS LASER DOPPLER LINE SCANNER (K063561)Moor Instruments, Ltd.2007-01-19
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE (K063597)bioMerieux, Inc.2007-01-19
THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 (K062868)Flowcardia, Inc.2007-01-19
ACCIN UNI-KNEE SYSTEM (K063782)Accin Corporation2007-01-19
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS (K063124)Integra Lifesciences Corp.2007-01-19
A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR (K062027)A&D Engineering, Inc.2007-01-19
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM (K062849)Smith & Nephew, Inc.2007-01-19
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (K063208)Diagnostic Chemicals , Ltd.2007-01-19
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K063417)Medtronic Sofamor Danek2007-01-18
MICROPLASTY TIBIAL TRAYS (K063732)Biomet Manufacturing Corp2007-01-18
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT (K063211)Stelkast Company2007-01-18
NUVASIVE ACP4 SYSTEM (K062590)Nuvasive, Inc.2007-01-18
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 (K062877)Vascular Solutions, Inc.2007-01-18
HAIRMAX LASERCOMB (K060305)Lexington International, LLC2007-01-18
MODIFICATION TO VECTORVISION TRAUMA (K062358)Brainlab AG2007-01-17
EXPEDIUM SPINE SYSTEM (K063741)Depuy Spine, Inc.2007-01-17
SEPRAMESH, MODEL 5959-1214 (K063739)Genzyme Corporation2007-01-17
COBAS INTEGRA C 111 (K063744)Rochdiag2007-01-17
VSPSPN (K063438)Tecres S.P.A.2007-01-17
PREMIO (K060465)Peters Surgical2007-01-17
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM (K062918)KARL STORZ Endoscopy-America, Inc.2007-01-17
TROCASYS (K063528)PAJUNK GmbH Medizintechnologie2007-01-17
3 SERIES PHOTOTHERAPY CABINET (K063621)Daavlin Co.2007-01-17
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T (K062009)Aesculap, Inc.2007-01-17
SOCK IT! ORAL PAIN GEL (K063148)Merlin Group Dba Mcmerlin Dental Company2007-01-17
NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 (K063539)Nordicicemedical AS2007-01-17
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC (K063653)Micrus Endovascular Corporation2007-01-17
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 (K063429)Generic Medical Device, Inc.2007-01-17
FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 (K063736)Pdg Product Design Group, Inc.2007-01-17
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Every clearance here is in the API, with alerts when new ones post.