Atlas FDA

2005

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

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RecordFirmDate
HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 (K042719)Home Health Technology Co., Ltd.2005-02-03
REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM (K043257)Ep Technologies, Inc.2005-02-03
PIONEER ANTERIOR CERVICAL PLATE SYSTEM (K043066)Pioneer Surgical Technology2005-02-03
SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY (K050161)Conmed Electrosurgery2005-02-03
TRANSMITTER, ZS-940PA SERIES (K043517)Nihon Kohden America, Inc.2005-02-03
SYNTHES 3.5MM CORTEX SCREWS (K043185)Synthes (Usa)2005-02-03
NANOSS BONE VOID FILLER (K050025)Angstrom Medica, Inc.2005-02-03
MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K043321)Medtronic Sofamor Danek2005-02-03
MODIFIED ACUMEN SHEATH, MODEL TTWO767 (K050015)Acumen Medical, Inc.2005-02-03
TRELLIS-8 PERIPHERAL INFUSION SYSTEM (K050147)Bacchus Vascular, Inc.2005-02-03
SIGN FIN NAIL (K043200)Surgical Implant Generation Network (Sign)2005-02-03
G-LIGHT (K050059)GC America, Inc.2005-02-03
FOOTHILLS SURGICAL DRAPES (K041224)Foothills Industries, Inc.2005-02-03
SYNGO INSPACE 4D (K043469)Siemens AG Medical Solutions2005-02-03
ASSIST HEADER CLEANER (K043126)Alcavis International, Inc.2005-02-03
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (K042780)Prosurg, Inc.2005-02-03
MEDCOMP SPLIT-CATH II (K040318)Medcomp2005-02-03
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER (K043371)Biomerix Corporation2005-02-03
59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS (K040303)Hydrogel Vision Corporation2005-02-02
GE LOGIQ TWIN (K050126)General Electric Co.2005-02-02
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS (K043246)C.R. Bard, Inc.2005-02-02
CERVEX-BRUSH COMBI (K043369)Rovers Medical Devices B.V.2005-02-02
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS (K031782)Medtronic Sofamor Danek2005-02-01
NOBELRONDO DENTAL CERAMIC - ZIRCONIA (K043312)Nobel Biocare USA, LLC2005-02-01
COOLTOUCH, MODEL CT3S (K043046)New Star Lasers, Inc.2005-02-01
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL (K043233)Efratgo, Ltd. HI Tech Bio-Surgical2005-02-01
UPDATED SLIP UROLOGY INTRODUCER SHEATH (K042531)Percutaneous Systems, Incorporated2005-02-01
BISCOVER LV (K043168)Bisco, Inc.2005-02-01
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL (K050102)Megadyne Medical Products, Inc.2005-02-01
VERTEBRON PSS PEDICLE SCREW SYSTEM (K043152)Vertebron, Inc.2005-02-01
D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR (K043323)Dideco S.R.L.2005-02-01
TESCERA OPAQUER POWDER/SCULPTING RESIN (K042804)Bisco, Inc.2005-02-01
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES (K043540)Westcon Contact Lens Co., Inc.2005-02-01
LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800 (K050087)Lerado Oversea Ltd. Twn Branch (Bvi)2005-02-01
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K043475)Shijiazhuang Winful Plastic Co., Ltd.2005-02-01
OMNIPRO SYSTEM (K050143)Mays and Associates, Inc.2005-02-01
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (K050067)First Quality Hygienic, Inc.2005-02-01
MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K043151)Medtronic Sofamor Danek2005-02-01
MODEL SC-3008 SEQUENTIAL CIRCULATOR (K043423)Bio Compression Systems, Inc.2005-02-01
VITELCARE TURTLE, MODEL 400 (K043368)Visual Telecommunications Network, Inc.2005-02-01
SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES (K043270)Zimmer GmbH2005-01-31
MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER (K042937)Vascular Solutions, Inc.2005-01-31
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 (K043346)Genesis Medical LLC2005-01-31
BEAM MODULATOR, MODEL 4513 332 8000 (K042794)Elekta , Ltd.2005-01-31
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 (K043460)Olympus America, Inc.2005-01-31
DYNAFLO BYPASS GRAFT (K050049)Bard Peripheral Vascular, Inc.2005-01-31
R605 FACS COLLIMETER (K050092)Omega Medical Imaging, Inc.2005-01-31
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC (K050026)Roche Diagnostics2005-01-31
CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT (K050069)Cutera, Inc.2005-01-31
IN EXAM INTRAORAL DENTAL X-RAY SYSTEM (K050019)Kavo America2005-01-31
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES (K043173)Lumenis, Ltd.2005-01-31
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K041630)Cardiovascular Systems Incorporated2005-01-31
AMADEUS II EPIKERATOME (K043150)Sis Ltd., Surgical Instrument Systems2005-01-31
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359 (K050121)Zimmer, Inc.2005-01-31
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM (K050099)Kontron Medical Systems Sas2005-01-28
POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS) (K043014)Shijiazhuang Tillotson Rubber Products Co., Ltd.2005-01-28
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0 (K043290)Neurognostics, Inc.2005-01-28
20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB (K043430)Totoku Electric Co., Ltd.2005-01-28
ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) (K042278)Oral Osteodistraction, L.P.2005-01-28
NEUROMONICS TINNITUS TREATMENT (K043274)Neuromonics Pty, Ltd.2005-01-28
INFANT FEEDING TUBE (K042112)Marian Medical, Inc.2005-01-28
MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD (K042321)Biomet Manufacturing Corp2005-01-28
PALAIMPACT (K043504)Heraeus Kulzer, Inc.2005-01-28
MEDTRONIC STRATAVARIUS (K041992)Medtronic Neurosurgery2005-01-28
PACHYCAM (K041841)Oculus Optikgerate GmbH2005-01-28
EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 (K043487)Aizu Olympus Co., Ltd.2005-01-28
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX (K043607)Respironics, Inc.2005-01-28
RADIN, MODEL V 3.0 (K043483)Sohard AG2005-01-28
BIOMOVE 3000 (K042650)Curatronic, Ltd.2005-01-27
HORIZON ANGIO CATHLAB (K043564)Mennen Medical , Ltd.2005-01-27
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037 (K042818)Matsushita Electric Works, Ltd.2005-01-27
AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 (K042623)St. Jude Medical, Daig Division, Inc.2005-01-27
SOLITUDE UNIPOLAR HEAD (K042973)Ortho Development Corp.2005-01-27
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS (K043072)Gen-Probe, Inc.2005-01-27
AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 (K043550)Amplife Corporation2005-01-27
F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK (K042129)Cedic S.R.L.2005-01-27
FUSION FAST (K043471)GC America, Inc.2005-01-27
LAPAROCISION SCOPE CONTROLLER SYSTEM (K050027)Gmp/Companies, Inc.2005-01-27
RANDOX PHENCYCLIDINE ASSAY (K043071)Randox Laboratories, Ltd.2005-01-27
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P (K043065)Edwards Lifesciences, LLC2005-01-26
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 (K043596)Theragenics Corp.2005-01-26
BEWELL, MODEL SC 20 (K043326)Cycling and Health Tech. Industry R&D Center2005-01-26
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 (K043583)Wrightmedicaltechnologyinc2005-01-26
GEODESIC PHOTOGRAMMETRY SYSTEM (K043309)Electrical Geodesics, Incorporated2005-01-26
LSA HELIUM (K042596)Lifestand2005-01-26
LDL-EX SEIKEN ASSAY KIT (K043264)Denka Seiken Co., Ltd.2005-01-26
CARDIOSTATION-100 (CS-100) (K041031)Us Clover Co.2005-01-26
DISTAL RADIO-ULNAR JOINT IMPLANT (K040497)Aptis Medical, LLC2005-01-26
SONOSURG TROCAR (K042160)Aomori Olympus Co., Ltd.2005-01-25
GC TION GINGIVAL PROTECTOR (K043301)GC America, Inc.2005-01-25
EQUESTRA FLUID DELIVERY SYSTEM (K043568)Medtronic Sofamor Danek2005-01-25
V.A.C. GRANUFOAM SILVER DRESSING (K041642)Kinetic Concepts, Inc.2005-01-25
I-PROMOTIONS CONTACT LENS CASE (K042578)I-Promotions, Inc.2005-01-25
MYLAB 15 / MYLAB 20, MODEL 2700 (K043588)Pie Medical2005-01-25
VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS (K042594)Vanguard Medical Concepts, Inc.2005-01-25
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (K040685)Osteoimplant Technology, Inc.2005-01-25
INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 (K050005)Intuitive Surgical, Inc.2005-01-25
DVI CURING LIGHT (K043530)Designs For Vision, Inc.2005-01-25
ELEKTA NEUROMAG WITH MAXWELL FILTER (K050035)Elekta Neuromag OY2005-01-25
HYDROGUM SOFT (K043118)Zhermack S.P.A.2005-01-24
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