Atlas FDA

2005

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

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RecordFirmDate
IPLAN RT FIBERTRACKING (K052220)Brainlab AG2005-09-30
VISANTE OCT (K051789)Carl Zeiss Meditec, Inc.2005-09-30
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML (K052250)Becton, Dickinson & CO2005-09-30
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES (K051944)Lumenis, Inc.2005-09-30
HUANQIU HEATING LAMP (K052063)A & A Medical Supplies, Inc.2005-09-30
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE (K052273)Pt Mahakarya Inti Buana2005-09-30
CARTO RMT EP NAVIGATION SYSTEM (K042681)Biosense Webster, Inc.2005-09-29
LINEAGE HA ACETABULAR SHELLS (K043099)Wrightmedicaltechnologyinc2005-09-29
VITEK 2 GRAM NEGATIVE TIGECYCLINE (K052311)bioMerieux, Inc.2005-09-29
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER (K052083)Biosense Webster, Inc.2005-09-29
POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS (K052415)Power Medical Interventions, Inc.2005-09-29
MERRIES UNI-OSTEO, MODEL CS30250-CS10102 (K051698)Merries International, Inc.2005-09-29
VICRYL * MESH BAG (K051701)ETHICON, Inc.2005-09-29
COPELAND EAS HUMERAL RESURFACING HEADS (K051843)Biomet, Inc.2005-09-29
ADVANTA T-GRAFT (K051332)Atrium Medical Corp.2005-09-29
SITE-RITE 5 ULTRASOUND SYSTEM (K052517)C.R. Bard, Inc.2005-09-29
REFSTAR RMT EXTERNAL REFERENCE PATCH (K042998)Biosense Webster, Inc.2005-09-29
RINGLOC BI-POLAR ACETABULAR COMPONENT (K051569)Biomet, Inc.2005-09-29
OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (K052027)Osmetech, Inc.2005-09-29
CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR (K052009)Conmed Corporation2005-09-28
FUSION CURING LIGHT (K052593)Dentlight, Inc.2005-09-28
LOW PROFILE PLATE AND SCREW SYSTEM (K052614)Arthrex, Inc.2005-09-28
THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 (K051861)Savion Industries, Ltd.2005-09-28
CERAMENT BONE VOID FILLER (K051951)Bonesupport AB2005-09-28
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER (K052232)Vascular Solutions, Inc.2005-09-28
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS (K052131)Depuy Spine, Inc.2005-09-28
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA (K051940)Sis Ltd., Surgical Instrument Systems2005-09-28
MFCD 1219, MFCD 1219 TS (K052478)Barcoview2005-09-28
CAREVENT ATV+ AND CAREVENT MRI (K051469)O-Two Medical Technologies, Inc.2005-09-28
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 (K052309)Saehan Corp.2005-09-27
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM (K052172)Hitachi Medical Systems America, Inc.2005-09-27
B-CARE POWDER FREE LATEX EXAMINATION GLOVES (K051404)B-Care Industries Co., Ltd.2005-09-27
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K052434)GE Medical Systems2005-09-27
EZ-JECT (K051667)Indolor, Ltd.2005-09-27
ACCOLADE RPS HIP STEM (K052542)Stryker Orthopaedics2005-09-27
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (K052422)Flow X-Ray Corp.2005-09-27
GE DATEX-OHMEDA ENGSTROM CARESTATION (K051895)Datex-Ohmeda, Inc.2005-09-27
E-POLY (VITAMIN E) ACETABULAR LINERS (K050327)Biomet, Inc.2005-09-27
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR (K051865)Terumo Medical Corp.2005-09-27
ARTHREX TENODESIS FAMILY (K051726)Arthrex, Inc.2005-09-27
PORTAL GRAVITY SYSTEM (K052579)Portal, Inc.2005-09-27
LCR (K052235)3M Company2005-09-27
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) (K051887)Carleton Life Support Systems, Inc.2005-09-27
ACTIHEART (K052489)Respironics, Inc.2005-09-27
MATRIX HOLTER SYSTEM, MODEL M12 (K051730)Global Instrumentation, LLC2005-09-26
ASAHI TORNUS SUPPORT CATHETER (K051772)Asahi Intecc Co., Ltd.2005-09-26
ACCOLADE HFX FEMORAL STEM (K051741)Stryker Orthopaedics2005-09-26
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE (K052373)Quill Medical, Inc.2005-09-26
AXXESS BUTTERFLY ANCHOR (K052418)Advanced Neuromodulation Systems2005-09-26
SYRYKER SORANO WHEELCHAIR (K051369)Stryker Canada2005-09-26
HILT FAMILY LASER: HILT I, HILT II, HILT III (K051537)Cynosure, Inc.2005-09-26
WU'S POWERED WHEELCHAIR, MAMBO 2 (K052559)Wu'S Tech Co., Ltd.2005-09-26
NISSIN SERIES MECHANICAL WHEELCHAIR (K052521)Nissin Medical Industries Co., Ltd.2005-09-26
TRANS1 FACET SCREWS (K051856)Trans1 Incorporated2005-09-26
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS (K050637)Ortho Development Corp.2005-09-23
I-NEB AAD SYSTEM (K042991)Profile Therapeutics Plc2005-09-23
AV-S ANAESTHESIA VENTILATOR (K051222)Penlon Limited2005-09-23
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM (K052056)Thermo-Electron Corp.2005-09-23
NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702 (K051835)Norm Pacific Automation Corp.2005-09-23
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER (K051459)Sysmex America, Inc.2005-09-23
REPROCESSED PHACOEMUISIFICATION TIPS (K050518)Alliance Medical, Inc.2005-09-23
VANISHPOINT I.V. CATHETER (K051355)Retractable Technologies, Inc.2005-09-23
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR (K052554)Versamed Medical Systems, Inc.2005-09-23
SURGISIS STAPLE LINE REINFORCEMENT II (K051048)Cook Biotech, Inc.2005-09-23
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS (K052245)Lar Mfg., LLC2005-09-23
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM (K052376)Medtronic Sofamor Danek2005-09-23
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 (K050448)Horiba Abx2005-09-23
SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM (K051859)Sin Sistema DE Implante Nacional Ltda2005-09-23
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 (K051629)Blease USA, Inc.2005-09-23
SYNTHES PANGEA SYSTEM (K052123)Synthes (Usa)2005-09-23
SAF-T-SYRINGE/SAF-T-NEEDLE (K051762)Safety Medical International, Incorporated2005-09-23
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (K051978)Implex Corp.2005-09-23
VERTEX RECONSTRUCTION SYSTEM (K052402)Medtronic Sofamor Danek2005-09-23
21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) (K052199)Totoku Electric Co., Ltd.2005-09-22
CYSTOGLIDE DILATING INTRODUCER SHEATH (K052134)Percutaneous Systems, Inc.2005-09-22
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C (K052372)Medtronic Perfusion Systems2005-09-22
SIMTEC IM-MAXX 2 OPTION (K052315)Siemens Medical Solutions USA, Inc.2005-09-22
SYNGO IMAGING VERSION V20A (K052461)Siemens AG Medical Solutions2005-09-22
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 (K052047)Avent America, Inc.2005-09-22
TRIAGE BNP TEST, MODEL 98000XR (K051787)Biosite Incorporated2005-09-22
ACUSON SEQUOIA ULTRASOUND SYSTEM (K052410)Siemens Medical Solutions USA, Inc.2005-09-22
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM (K052317)Stryker Spine2005-09-21
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM (K051697)Medical Device Advisory Development Group2005-09-21
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR (K051540)Inovo, Inc.2005-09-21
GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 (K052274)Guidant Corporation2005-09-21
POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE (K052460)Ramsoft, Inc.2005-09-21
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS (K052091)Trek Diagnostic Systems, Inc.2005-09-21
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (K052293)Ge Medical Systems, LLC2005-09-21
NIO 2MP-20 AND E-2620 S (K052276)Barcoview2005-09-21
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 (K052447)Analogic Corp.2005-09-21
HIPAX MEDICAL IMAGING SOFTWARE (K052411)Steinhart Medizinsysteme GmbH2005-09-21
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT (K052452)Olympus Medical Systems Corporation2005-09-21
AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER (K052332)Trudell Medical Intl.2005-09-21
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 (K051494)Cr Tech, Ltd.2005-09-21
REPROCESSED EXTERNAL FIXATION DEVICE (K051957)Sterilemed, Inc.2005-09-21
TRITON/TRU-TRAC/TX TRACTION DEVICES (K051938)Chattanooga Group2005-09-21
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 (K052329)Innovative Neurotronics, Inc.2005-09-21
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM (K051678)Synthes (Usa)2005-09-21
OXY-SERVE II OXYGEN CONSERVING REGULATOR (K051988)Superior Products, Inc.2005-09-21
20G SMA LASER FIBER, MODEL LF100 (K050807)Ophthalmed, LLC2005-09-21
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Every clearance here is in the API, with alerts when new ones post.