Atlas FDA

2007

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

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RecordFirmDate
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT (K070489)Heartway Medical Products Co., Ltd.2007-03-14
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL (K063775)Phadia US, Inc.2007-03-14
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER (K070279)Cordis Neurovascular, Inc.2007-03-14
MODIFICATION TO S4 SPINAL SYSTEM (K062327)Aesculap, Inc.2007-03-14
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR (K070096)Gx Corporation Sdn Bhd2007-03-14
P&F POWER WHEELCHAIR, HC-510 (K070350)P & F Brother Ind., Corp.2007-03-14
TINA-QUANT D-DIMER TEST SYSTEM (K062203)Roche Diagnostics Corp.2007-03-14
JOYKEY SURGICAL GOWNS (STERILE) (K062479)Joykey Industryial , Ltd.2007-03-14
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE (K070538)Dentsply Intl.2007-03-14
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K070262)Oxoid , Ltd.2007-03-14
CONCEIVEX CONCEPTION KIT (K063227)Conceivex, Inc.2007-03-14
CTBOX CERVICAL/LUMBAR TRACTION (K063353)Circular Traction Supply, Inc.2007-03-14
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM (K061881)Takiron Co., Ltd.2007-03-14
SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA (K063859)Surgiquest, Inc.2007-03-14
VERTE-STACK SPINAL SYSTEM (K070173)Medtronic Sofamor Danek, Inc.2007-03-14
TENDERFLOW PERIATRIC ARTERIAL CANNULA (K063618)Terumo Cardiovascular Systems Corp.2007-03-13
LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM (K070285)Life Spine2007-03-13
ARCUATE VERTEBRAL AUGMENTATION SYSTEM (K063248)Medtronic Sofamor Danek2007-03-13
AUDIT MICROCV LIPIDS LINEARITY SET (LOW) (K070223)Aalto Scientific, Ltd.2007-03-13
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM (K062872)Synthes (Usa)2007-03-13
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 (K070421)GE Healthcare2007-03-13
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH (K060452)Neo-Genesis2007-03-13
RETRO-TECH DRESSING (K060832)Retro-Tech, LLC2007-03-13
ELLEX SLIT LAMP, MODEL 30XL (K063352)Takagi Seiko Co., Ltd.2007-03-13
GENGIGEL MOUTHRINSE (K053342)Ricerfarma Srl2007-03-13
NIGHT GUARD (K061122)Alpine Oral Care, LLC2007-03-12
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH (K063647)Thermo Electron OY2007-03-12
GRADIA DIRECT X (K070190)GC America, Inc.2007-03-12
SATURN 3 LASER SYSTEM (K060764)Research Instruments , Ltd.2007-03-12
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM (K063712)C.R. Bard, Inc.2007-03-12
QUANTA LITE H-TTG/DGP SCREEN (K070083)Inova Diagnostics, Inc.2007-03-12
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR (K070308)X-Cel Contacts2007-03-12
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS (K062994)Biomet Manufacturing Corp2007-03-09
ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT (K070378)AngioDynamics, Inc.2007-03-09
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES (K062875)Endogastric Solutions, Inc.2007-03-09
TCA 5R / 5S (K070123)Dornier Medtech America, Inc.2007-03-09
ECONOLITH EM1000 (K063504)Medispec, Ltd.2007-03-09
ATLAS SPINE VERTEBRAL BODY REPLACEMENT (K063464)Atlas Spine, Inc.2007-03-09
REPEATER PUMP II TUBE SETS (K062909)Baxa Corp.2007-03-09
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (K062659)Kirwan Surgical Products, Inc.2007-03-09
ORISON EMBRACE SYSTEM (K070477)Orison Corporation2007-03-09
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A (K070370)Totoku Electric Co., Ltd.2007-03-09
EXPRESSWAY INTERMITTENT CATHETER (K061766)Percutaneous Systems, Incorporated2007-03-09
PHILIPS ESSENTA DR (K070528)Philips Medical Systems GmbH, Dmc2007-03-09
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR (K070508)C.R. Bard, Inc.2007-03-09
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS (K070369)Biomet, Inc.2007-03-09
FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE (K070275)Rubicor Medical, Inc.2007-03-09
REMSTAR AFLEX CPAP SYSTEM (K063830)Respironics Inc., Sleep & Home Respiratory Group2007-03-09
CARDIOCT (K070226)Shina Systems , Ltd.2007-03-09
ATRIUM PROLITE ULTRA S MESH (K070192)Atrium Medical Corp.2007-03-08
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (K070084)Est. Anthogyr2007-03-08
ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) (K063149)T.O.A.D.S., LLC2007-03-08
SERIES II CONSTRAINED ACETABULAR LINERS (K063552)Howmedica Osteonics Corp.2007-03-08
LIV BREAST SELF EXAMINATION AID (K070344)Liv International USA, Inc.2007-03-08
SYSTEM 12 CONSTRAINED ACETABULAR LINERS (K063550)Howmedica Osteonics Corp.2007-03-08
PCA CONSTRAINED ACETABULAR LINERS (K063445)Howmedica Osteonics Corp.2007-03-08
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM (K063473)Synthes (Usa)2007-03-08
SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES (K063001)Lasering S.R.L.2007-03-07
SYNTHES (USA) ELBOW HINGE FIXATOR (K063832)Synthes (Usa)2007-03-07
BD DIRECTIGEN EZ FLU A+B TEST (K063689)Becton, Dickinson & CO2007-03-07
PRE-LOADED VISICOIL (K070305)Radiomed Corporation2007-03-07
SURGI-WRAP MAST TENDON SHEET (K063648)Mast Biosurgery USA, Inc.2007-03-07
BP-200 PLUS (K063814)Schiller AG2007-03-07
OTOGRAM, CA3350 (K070118)Tympany, Inc.2007-03-07
TROKABONE, TROKABONE STERNAL (K070179)PAJUNK GmbH Medizintechnologie2007-03-07
ULTRA LOW PROFILE RONGEUR (K062711)Baxano, Inc.2007-03-07
OPTI (K063646)Camsight Co., Inc.2007-03-07
CLAROS DENTAL LASER SYSTEM (K063152)Elexxion AG2007-03-07
ALPHA-CORE DC (K070191)Dental Technologies, Inc.2007-03-07
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (K063694)Bausch & Lomb, Inc.2007-03-07
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY (K063486)Becton, Dickinson & CO2007-03-07
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K070026)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-07
CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER (K063563)Cordis Europa, N.V.2007-03-07
DEPUY ASR TAPER SLEEVE ADAPTER (K070359)DePuy Orthopaedics, Inc.2007-03-06
FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS (K070162)Valleylab,A Division of Tyco Healthcare Group LP2007-03-06
PLC SUTURE ANCHOR (K063726)Smith & Nephew Inc., Endoscopy Div.2007-03-06
SAF-T-SYRINGE- 0.5 AND 1ML/CC (K063340)Safety Medical International, Incorporated2007-03-06
ZIRCONIA IMPLANT (K061971)Nobel Biocare AB2007-03-06
ARTHREX CROSSPIN, MODEL AR-1964P (K063719)Arthrex, Inc.2007-03-06
VAP-NT CHOLESTEROL TEST (K062026)Atherotech, Inc.2007-03-06
ULTRASOUND SCANNER PROFOCUS, MODEL 2202 (K070077)B-K Medical Aps2007-03-05
GUARDIANCATHETER-URINARY DRAINAGE CATHETER (K063795)Marian Medical, Inc.2007-03-05
SEKURIT SHARPS COLLECTION CONTAINER (K063722)Techen Safety, Inc.2007-03-05
PS SERIES (K061622)Photonic Optische Gerate Gesmbh & Cokg2007-03-05
T2 SCEPTOR SPINAL SYSTEM (K063491)Medtronic Sofamor Danek2007-03-05
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE (K063673)Innovacon, Inc.2007-03-05
DBX DEMINERALIZED BONE MATRIX MIX (K063676)Musculoskeletal Transplant Foundation2007-03-05
LEKSELL GAMMA KNIFE PERFEXION (K063512)Elekta Instrument AB2007-03-05
JOYKEY SURGICAL DRAPES (STERILE) (K062480)Joykey Industryial , Ltd.2007-03-05
CADWELL EASYNET OXIMETER MODULE (K061706)Cadwell Laboratories, Inc.2007-03-05
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 (K063786)Olympus Medical Systems Corporation2007-03-05
EARCHECK ACOUSTIC REFLECTOMETER (K070312)Innovia Medical, LLC2007-03-02
SYNTERMED LIVE (K070089)Syntermed, Inc.2007-03-02
OSTEOMED HEADLESS CANNULATED SCREW SYSTEM (K063298)Osteomed LP2007-03-02
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE (K063734)Atlantis Components, Inc.2007-03-02
PROMOS MODULAR SHOULDER SYSTEM (K063578)Plus Orthopedics AG2007-03-02
CO2 LASER SYSTEM, MODEL C-LAS (K063698)Clinicon Corp.2007-03-02
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM (K063792)Osteomed LP2007-03-02
TOP FINE (K063466)Daejin Tech Medical Manufacturing Co., Ltd.2007-03-02
MODIFICATION TO COLLAWOUND DRESSING (K070269)Collamatrix Co., Inc.2007-03-02
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Every clearance here is in the API, with alerts when new ones post.