Atlas FDA

2005

3,156 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (K043526)Noble Fiber Technologies, Inc.2005-03-10
TSX-201A AQUILION LB CT SCANNER (K050458)Toshiba America Medical Systems, In.C2005-03-10
PRE-POWDERED VINYL EXAM GLOVES (K042951)Zibo Hengchang Plastic & Rubber Products Co., Ltd.2005-03-10
HEMOSIL D-DIMER (K050278)Instrumentation Laboratory CO2005-03-10
RELIANT LASER II SYSTEM AND ACCESSORIES (K042319)Reliant Technologies, Inc.2005-03-10
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 (K050355)Tissue Science Laboratories, Plc2005-03-09
POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043478)Shijaizhuang Brilliant Ocean Plastic Co., Ltd.2005-03-09
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K042797)Gambro Renal Products2005-03-09
SHARPOINT LUKENS BONE WAX (K050292)Surgical Specialties Corp2005-03-09
SIS FISTULA PLUG (K050337)Cook Biotech, Inc.2005-03-09
AURA CPAP SYSTEM (K042945)Aeiomed, Inc.2005-03-09
TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 (K042107)Tung FU Electric Co., Ltd.2005-03-09
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM (K050364)Valley Forge Scientific Corp.2005-03-09
DIASYS INTEGRA II (K042109)Novacor France2005-03-09
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT (K050148)Mentor Corporation2005-03-09
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K042074)Vanguard Medical Concepts, Inc.2005-03-09
AURORA SR AND SRA APPLICATOR (K050452)Syneron Medical, Ltd.2005-03-09
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE (K050304)Conmedcorp2005-03-08
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG (K050111)Cobe Cardiovascular, Inc.2005-03-08
PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K050447)Dideco S.R.L.2005-03-08
MEDLINE SURGICAL GOWNS (K043585)Medline Industries, Inc.2005-03-08
DRAGON HEART I.V. SET (K043235)Dragon Heart Medical Devices Co., Ltd.2005-03-08
YIXIN SAFETY SYRINGE (K042102)Jiangxi Sanxin (Eversincere) Medical Devices Group2005-03-08
ARCOMXL POLYETHYLENE LINERS (K042051)Biomet, Inc.2005-03-08
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS (K043017)Medline Industries, Inc.2005-03-08
CLEVER CHEK TD-3213 (K042795)Taidoc Technology Corporation2005-03-07
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN (K050275)Inion , Ltd.2005-03-07
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS (K043101)Zimmer, Inc.2005-03-07
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM (K043578)Solco Biomedical Co., Ltd.2005-03-07
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA (K043433)Hycor Biomedical , Ltd.2005-03-07
ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE (K050052)Atlantis Components, Inc.2005-03-07
DIVER C.E. CATHETER (K050276)Invatec Innovative Technologies, S.R.L.2005-03-07
NEO IMPLANT SYSTEM (K043195)Neoss, Ltd.2005-03-07
SYNTHES RAPID RESORBABLE TACK SYSTEM (K050204)Synthes (Usa)2005-03-04
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III (K050186)Ameditech, Inc.2005-03-04
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 (K043357)Linde Medical Sensors AG2005-03-04
NEUROTECH KNEEHAB (K024258)Bio-Medical Research, Ltd.2005-03-04
FUSION PUTTY TYPE (K043493)GC America, Inc.2005-03-04
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (K050338)Akers Biosciences, Inc.2005-03-04
BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH (K050205)Flowmedica, Inc.2005-03-04
SPYGLASS DIRECT VISULATION PROBE (K050403)Boston Scientific Corp2005-03-04
FEATHERLIFT EXTENDED APTOS THREAD (K043591)Kmi Kolster Methods, Inc.2005-03-04
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM (K040202)Salter Labs2005-03-04
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (K050175)Spacelabs Medical, Inc.2005-03-04
SYNTHES (USA) LCP MODULAR FOOT PLATES (K050110)Synthes (Usa)2005-03-04
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 (K050413)Amplife Corporation2005-03-04
CONTOUR NECKLIFT THREADS (K050247)Surgical Specialties Corp2005-03-04
DEPUY CAS KNEE INSTRUMENTATION (K043223)DePuy Orthopaedics, Inc.2005-03-04
MILTEX LAPAROSCOPIC INSTRUMENTS (K043013)Miltex, Inc.2005-03-04
BARI-KAD PACKING DEVICE (K050318)Bioenvelop Agro, Inc.2005-03-04
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM (K050048)Howmedica Osteonics Corp.2005-03-04
DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 (K043331)Hubdic Co., Ltd.2005-03-04
PRISMATIK CERAMIC (K050144)Glidewell Laboratories2005-03-03
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS (K043288)Intuitive Surgical, Inc.2005-03-03
DUAL LUMEN CATHETER (K043581)Acmi Corporation2005-03-03
A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR (K043217)A&D Engineering, Inc.2005-03-03
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE (K050162)Medtronic Xomed, Inc.2005-03-03
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 (K043486)Topcon Medical Laser Systems, Inc.2005-03-03
LAZRPULSR 4X (K041565)Led Healing Light, LLC2005-03-03
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 (K041374)Idev Technologies, Inc.2005-03-02
STRYKER SPINE TRIO PS (K043180)Stryker Spine2005-03-02
GYRUS PLASMA SKIN RESURFACING SYSTEM (K041999)Gyrus Medical, Inc.2005-03-02
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR (K043133)Ceremed , Inc.2005-03-02
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER (K050227)Linvatec Corp.2005-03-02
GALEO FOCUS GUIDE WIRE (K042373)Biotronik, Inc.2005-03-02
TULIP CONDOM (K050360)Shanghai Latex Factory2005-03-01
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER (K043120)Datex-Ohmeda, Inc.2005-03-01
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER (K043513)Sterilmed, Inc.2005-03-01
STERILEMED REPROCESSED IVUS IMAGING CATHETER (K043453)Sterilmed, Inc.2005-03-01
TCM40 MONITORING SYSTEM (K043003)Radiometer Medical Aps2005-03-01
C-CO2 COLORIMETRIC CO2 INDICATOR (K050066)Marquest Medical Products, Inc.2005-03-01
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE (K043398)Neometrics, Inc.2005-03-01
SOMATOM EMOTION 16 (K050297)Siemens Medical Solution, Inc. USA2005-03-01
MPS (OR MPS-T) (K041838)Innerspace, Inc.2005-03-01
TRIFIT 700 (K033646)Healthfirst Corp.2005-03-01
RESMED MERIDIAN MASK (K050142)Resmed, Ltd.2005-03-01
USGI SHAPELOCK ENDOSCOPIC GUIDE (K050253)Usgi Medical2005-02-28
IPACS PRISM-5.0 (K050298)Realtimeimage, Inc.2005-02-28
MODIFICATION TO ENDOVASCULAR GUIDE WIRE (K043457)Stereotaxis, Inc.2005-02-28
TRIAGE TOX DRUG SCREEN (K043242)Biosite Incorporated2005-02-28
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K041884)Mueller Water Conditioning, Inc.2005-02-28
SNORENTI (K032410)James P Boyd2005-02-28
VITEK 2 GRAM POSITIVE DAPTOMYCIN (K050075)bioMerieux, Inc.2005-02-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML (K050089)Becton, Dickinson & CO2005-02-28
CUSTODIOL (K043461)Dr. Franz Kohler Chemie GmbH2005-02-28
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) (K043425)Sheathing Technologies, Inc.2005-02-28
AIRIS ELITE RAPID BODY COIL (K050307)Hitachi Medical Systems America, Inc.2005-02-28
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 (K050326)Esaote, S.p.A.2005-02-28
MAGNETOM TRIO A TIM SYSTEM (K050200)Siemens Medical Solutions USA, Inc.2005-02-28
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (K042272)ACON Laboratories, Inc.2005-02-28
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER (K050100)Bionostics, Inc.2005-02-25
CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) (K041908)Medoc Ltd. Advanced Medical Systems2005-02-25
ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE (K043507)ACON Laboratories, Inc.2005-02-25
5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X. (K050303)Mesure Technology Co., Ltd.2005-02-25
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM (K050041)Synthes (Usa)2005-02-25
BIOBEAM NARROW BAND LIGHT THERAPY DEVICES (K042813)Life Without Pain, LLC2005-02-25
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM (K050347)Endocare, Inc.2005-02-25
BOSWORTH BOND (K043170)Harry J. Bosworth Co.2005-02-25
HOLTER RECORDER H3+ (K043010)Mortara Instrument, Inc.2005-02-25
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 (K050004)Philips Medical Systems2005-02-25
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Every clearance here is in the API, with alerts when new ones post.