Atlas FDA

2005

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

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RecordFirmDate
BASIS VERTEBRAL BODY SPACER (K051105)Medtronic Sofamor Danek2005-06-09
MODIFICATION TO: UNICAP SPECIFIC IGE (K051218)Pharmacia Diagnostics AB2005-06-09
STERLING INTERFERENCE SCREW ST (K050767)Regeneration Technologies, Inc.2005-06-09
REMOTE CARE MANAGEMENT SYSTEMS (RCMS) (K051470)Bl Healthcare, Inc.2005-06-08
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 (K051125)Abbott Laboratories2005-06-08
ON TRAK TESTCARD (K051235)Varian, Inc.2005-06-08
PRECEDENCE SPECT/CT IMAGING SYSTEM (K051351)Adac Laboratories2005-06-08
PREVAIL DENTAL IMPLANTS (K051189)Implant Innovations, Inc.2005-06-08
STELTHSTATION WIRELESS SURGEON MOUSE (K051029)Medtronic Surgical Navigation2005-06-08
FRESENIUS ART HEMOADSORPTION SYSTEM (K050273)Fresenius Medical Care North America2005-06-08
ON CALL MULTI-DRUG HOME TEST CUP (K050878)ACON Laboratories, Inc.2005-06-08
ENHANCE CLITORAL STIMULATION AID (K043480)Gynavations, Inc.2005-06-08
REXEED SERIES DIALYZERS (K051187)Asahi Kasei Medical Co., Ltd.2005-06-08
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] (K050916)Intra Luminal Therapeutics, Inc.2005-06-08
NOBELSPEEDY IMPLANTS (K050406)Nobel Biocare AB2005-06-08
PIEZOSURGERY DEVICE (K043408)Piezosurgery S.R.L.2005-06-08
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 (K051179)Boston Scientific Corp2005-06-08
IBOND NEXT GENERATION (K051006)Heraeus Kulzer,GmbH2005-06-07
SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM (K031196)Praxim2005-06-07
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY (K051103)Haag-Streit USA, Inc.2005-06-07
IMC DRAPES (K050538)Intl. Medsurg Connection, Inc.2005-06-07
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] (K050915)Intra Luminal Therapeutics, Inc.2005-06-07
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE (K051347)Kimberly-Clark Corp.2005-06-07
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER (K050371)Medrad, Inc.2005-06-07
PROTECT TOOTH DESENSITIZER (K050486)Sunstar Butler2005-06-07
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET (K051166)Gloveco, Inc.2005-06-07
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) (K050277)Hartalega Sdn Bhd2005-06-07
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 (K050713)Good Biotech Corp.2005-06-06
REPROCESSED ULTRASONIC SCALPELS (K043358)Alliance Medical Corp.2005-06-06
MAS IMMUNOSUPPRESSANT CONTROLS (K051074)Microgenics Corp.2005-06-06
COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING (K043296)Covalontechnologies, Inc.2005-06-06
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K050776)Misonix, Inc.2005-06-06
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K051043)Vanguard Medical Concepts, Inc.2005-06-06
SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR (K043306)Skylark Device & Systems Co., Ltd.2005-06-06
NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE (K051094)Terang Nusa Sdn Bhd2005-06-06
SPOTCHEM II LDH TEST (K050790)Arkray, Inc.2005-06-06
XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A (K043558)Chongqing Xinfeng Medical Instruments Co., Ltd.2005-06-06
CENTERPIECE PLATE FIXATION SYSTEM (K050082)Medtronic Sofamor Danek, Inc.2005-06-06
IMMEDIA PROTHROMBIN TIME SYSTEM (K050243)Farallon Medial, Inc.2005-06-06
KOO AMERICAS VALVE PEEP, MODEL KM-809 (K050918)Koo Americas, Inc.2005-06-06
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (K050008)Mentor Corp.2005-06-03
HEMCON BANDAGE AND HEMCON BANDAGE OTC (K043050)Hemcon, Inc.2005-06-03
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG (K050885)Olympus Medical Systems Corporation2005-06-03
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE (K041511)Sutures India Private Limited2005-06-03
TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER (K051334)Teratech Corp.2005-06-03
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K051152)Zibo Sinocare Plastic Products Co., Ltd.2005-06-03
COOL.CLICK (K050734)Bioject, Inc.2005-06-03
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM (K051304)Science Surgical Corporation2005-06-03
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 (K043574)Renal Solutions, Inc.2005-06-03
RIVA LIGHT CURE (K050870)Southern Dental Industries, Inc.2005-06-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML (K051138)Becton, Dickinson & CO2005-06-03
REPROCESSED TROCARS (K033591)Clearmedical, Inc.2005-06-03
KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 (K051127)Kika Medical, Inc.2005-06-03
IMBIBE BONE MARROW ASPIRATION NEEDLE (K050795)Orthovita, Inc.2005-06-03
WAGNER STERISET STERILIZATION CONTAINER (K041096)Wagner GmbH2005-06-03
CALLOS IMPACT AND INJECT BONE VOID FILLER (K051123)Skeletal Kinetics, LLC2005-06-03
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER (K050599)Boston Scientific Corp2005-06-03
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE (K041514)Sutures India Private Limited2005-06-03
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE (K041510)Sutures India Private Limited2005-06-02
STEALTHSTATION SYSTEM UPDATE (K050438)Medtronic Surgical Navigation Technologies2005-06-02
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE (K041512)Sutures India Private Limited2005-06-02
EZ SMART (K043340)Vip Diagnostics, LLC2005-06-02
FT FIBER OPTIC DELIVERY SYSTEMS (K050738)Fibertech GmbH2005-06-02
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P (K051036)Ethicon Endo-Surgery, Inc.2005-06-02
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE (K050947)United States Surgical, A Division of Tyco Healthc2005-06-01
REVOLIX AND REVOLIX JR (K051167)Allmed Systems, Inc.2005-06-01
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K050763)Vanguard Medical Concepts, Inc.2005-06-01
ZENO (K043377)Tyrell, Inc.2005-06-01
ORLUS MINI SCREW (K050568)Ortholution Co., Ltd.2005-06-01
ONYX II FINGER PULSE OXIMETER, MODEL 9550 (K051107)Nonin Medical, Inc.2005-06-01
MYLAB 70 ULTRASOUND IMAGING SYSTEM (K051308)Esaote, S.p.A.2005-06-01
MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 (K041897)Schaerer Mayfield USA, Inc.2005-06-01
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 (K051258)Eastman Kodak Company2005-06-01
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE (K050925)Shimadzu Corp.2005-06-01
GAMMAPLAN (K051022)Elekta Instrument AB2005-06-01
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES (K042297)Acta Vascular Systems, Inc.2005-06-01
AESKULISA TTG A AND AESKULISA TTG G (K042644)Aesku, Inc.2005-06-01
ABX ERYTROL (K050721)Horiba Abx2005-06-01
NICHOLS ADVANTAGE ALDOSTERONE ASSAY (K050784)Nichols Institute Diagnostics2005-06-01
ARCADIS AVANTIC (K051133)Siemens Medical Solutions USA, Inc.2005-06-01
FACEMASTER FACIAL TONING SYSTEM (K040871)Facemaster of Beverly Hills, Inc.2005-06-01
DIASORIN LIAISON CMV IGM/IGG (K040290)Diasorin S.P.A2005-06-01
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM (K050856)Ophthocare , Ltd.2005-05-31
MODEL TL-560 POWER SCOOTER (K051116)Teh Lin Prosthetic & Orthopaedic, Inc.2005-05-31
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE (K043442)Stryker Instruments2005-05-31
MODEL TL-360 POWER SCOOTER (K051118)Teh Lin Prosthetic & Orthopaedic, Inc.2005-05-31
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES (K050638)Lenstec, Inc.2005-05-31
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 (K043067)Bioarray Solutions, Ltd.2005-05-31
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT (K051086)Smith & Nephew, Inc.2005-05-31
AMT NANOCATH (K050557)American Medical Technologies, Inc.2005-05-27
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS (K051213)Abbott Laboratories, Inc.2005-05-27
VANGUARD REPROCESSED ARTHROSCOPIC WANDS (K043198)Vanguard Medical Concepts, Inc.2005-05-27
OMNITECH FULGURATING ELECTRODE (K050454)Omnitech Systems, Inc.2005-05-27
NEWDEAL ANKLE NAIL (K050882)New Deal, S.A.2005-05-27
MAXLOCK (K050868)Orthohelix Surgical Designs, Inc.2005-05-27
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML (K050946)Becton, Dickinson & CO2005-05-27
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO (K050006)C.R. Bard, Inc.2005-05-27
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 (K050453)Ivoclar Vivadent, Inc.2005-05-27
SURGI-WRAP MAST BIORESORBABLE SHEET (K050332)Mast Biosurgery USA, Inc.2005-05-27
CO VERTEBRAL BODY REPLACEMENT (K050348)Scient'X2005-05-27
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