Atlas FDA

2008

3,053 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DENTIS DENTAL IMPLANT SYSTEM (K073486)Dentis Co., Ltd.2008-04-04
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 (K072583)Maquet Cardiopulmonary, AG2008-04-04
BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2) (K073458)Btlock Srl2008-04-04
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 (K080806)Possis Medical, Inc.2008-04-04
EXPEDIUM 4.5MM SPINE SYSTEM (K073364)Depuy Spine, Inc.2008-04-04
IGG ANTI-ATHEROX TEST KIT (K072032)Corgenix, Inc.2008-04-04
WELLGRAFT PE II (K072170)Gwowei Technology Co., Ltd.2008-04-04
TETRIX CREAM (K071483)Coria Laboratories, Ltd.2008-04-04
CRYOMINI (K080735)Zimmer Elektromedizin GmbH2008-04-04
SAPPHIRE O/E ORAL EXAMINATION SYSTEM (K073483)Den-Mat Holdings, LLC2008-04-03
SPIRUS MEDICAL SURGICAL INSTRUMENT (K080042)Spirus Medical, Inc.2008-04-03
LTM-T SURGICAL MESH (K080353)Lifecell Corp.2008-04-03
BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202 (K080789)Sejoy Electronics & Instruments Co., Ltd.2008-04-03
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS (K073534)Candela Corp.2008-04-03
MODEL D DISC FORCE (K073132)North American Medical Corp (Nam)2008-04-03
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) (K080192)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2008-04-03
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM (K080191)Depuy Spine, Inc.2008-04-02
SMART-ROD (K070584)Duoject Medical Systems, Inc.2008-04-02
ONCOBIONIC SYSTEM (K080376)Oncobionic Incorporated2008-04-02
AP MEDICAL SHARPS CONTAINERS 0,6-12 LT. (K071517)A.B.M. Italia S.P.A2008-04-02
WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE (K080784)Ultraspect , Ltd.2008-04-02
MIMICS (K073468)Materialise NV2008-04-02
LD-I 75 AND LD-I 200 (K072551)Meditech International, Inc.2008-04-02
AESCULAP ENDOSCOPIC CLIP SYTEM (K080753)Aesculap, Inc.2008-04-02
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING (K073494)Taidoc Technology Corporation2008-04-02
TEM 3002G- HN DUAL TUNE HEAD COIL (K080820)Mr Instruments, Inc.2008-04-02
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 (K073445)Taidoc Technology Corporation2008-04-02
ERBE VIO ESU, MODEL VIO 200 S (K080715)Erbe USA, Inc.2008-04-02
BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS (K080557)Barrx Medical, Incorporated2008-04-02
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 (K080622)Optim, Inc.2008-04-02
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116 (K080593)Taidoc Technology Corporation2008-04-02
CONMED LINVATEC OSPREY DRILL SYSTEM (K080444)Conmed Linvatec2008-04-02
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K073434)Bipore, Inc.2008-04-01
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 (K073137)Apex BioTechnology Corp.2008-04-01
VPAP ST (K080131)Resmed, Ltd.2008-04-01
DUREX PLAY SOFT & SENSUAL LUBRICANT (K071626)Ssl Americas2008-04-01
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (K072658)Siemens Medical Solutions Diagnostics2008-04-01
ARTHROCARE ORTHOWAND SURGICAL DEVICE (K080610)Arthrocare Corp.2008-03-31
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP (K080698)Senorx, Inc.2008-03-31
RESPIRATORY HUMIDIFIER, MODEL MR850 (K073706)Fisher & Paykel Healthcare, Ltd.2008-03-31
INREACH SYSTEM (K080271)Superdimension, Ltd.2008-03-31
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS (K073075)Dentsply International, Inc.2008-03-31
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM (K070310)Brahms Aktiengesellschaft2008-03-31
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 (K080402)Encore Medical L.P.2008-03-28
SOYALA FULL FACE MASK GEL VENTED (K073673)Weinmann Gerate Fur Medizin GmbH + Co. KG2008-03-28
SPINOUS PROCESS PLATE SYSTEM (K073278)Nuvasive, Inc.2008-03-28
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION (K073550)Nihon Kohden America, Inc.2008-03-28
HOMECHECK MULTIPLE DRUG CUP TEST (K071489)Tianjin New Bay Bioresearch Co., Ltd.2008-03-28
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS (K072847)Hologic, Inc.2008-03-28
BLUE SKY BIO DENTAL IMPLANT SYSTEM (K073713)Blue Sky Bio, LLC2008-03-28
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (K073519)Kensey Nash Corp.2008-03-28
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH (K080228)Novamin Technology, Inc.2008-03-27
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES (K072400)Sgmp Co., Ltd.2008-03-27
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) (K072403)Sgmp Co., Ltd.2008-03-27
PORTRAIT PSR, MODEL 745915 (K073111)Rhytec Incorporated2008-03-27
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (K061907)GE Healthcare2008-03-27
AVS PL PEEK SPACERS, MODELS 48351 AND 48353 (K080758)Stryker Corp.2008-03-27
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 (K072185)Airistar Technologies, LLC2008-03-27
FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS (K072730)Dentsply Intl.2008-03-27
HABIB HEXABLATE 10 (K080717)Emcision , Ltd.2008-03-27
HD7 DIAGNOSTIC ULTRASOUND SYSTEM (K080548)Phillips Medical Systems2008-03-27
PECD-01 AND PECD QUICK-01 (K080514)3M Espe AG Dental Products2008-03-26
BELLA (K073262)Beekley Corp.2008-03-26
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE (K073671)Ndo Surgical, Inc.2008-03-26
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 (K080104)Vascular Solutions, Inc.2008-03-26
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW (K073342)Salvin Dental Specialties, Inc.2008-03-26
MODIFICATION TO: FOX PLUS PTA CATHETER (K080264)Abbott Vascular-Vascular Solutions2008-03-26
MCT-DIABETES (K073699)Mycare Team, Inc.2008-03-26
MODIFICATION TO PALOMAR LUX1540 HANDPIECE (K073583)Palomar Medical Products, Inc.2008-03-26
VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA (K063813)Ventlab Corp.2008-03-26
MTA ROOT CANAL SEALER (K080203)Dentsply Interntional2008-03-26
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY (K080184)I.T.S. Implantat-Technologie-Systeme GmbH2008-03-26
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 (K080183)Roche Diagnostics Corp.2008-03-25
SMALL INTESTINAL VIDEOSCOPE SYSTEM (K071254)Olympus Medical Systems Corporation2008-03-25
BIOFLEX (K072321)Biospine Co., Ltd.2008-03-25
E-VAC (K073455)New Leaf Medical, Inc.2008-03-25
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED (K072329)Biotronik, Inc.2008-03-25
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) (K080170)C.R. Bard, Inc.2008-03-25
AAP CANNULATED SCREW AND DARCO HEADED SCREW (K080101)Aap Implantate AG2008-03-25
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM (K072441)Tyson Bioresearch, Inc.2008-03-25
MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE (K073705)Shandong Qiaopai Group Co., Ltd.2008-03-24
DASH 2500 PATIENT MONITOR (K080157)Ge Medical Systems Information Technologies2008-03-24
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 (K080495)Philips Medical Systems2008-03-24
XPS 3000 SYSTEM (K073255)Medtronic Xomed, Inc.2008-03-24
CAYMAN BUTTRESS PLATE SYSTEM (K080302)K2m, Inc.2008-03-24
DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT (K070184)Ospol AB2008-03-24
VERTEBRON VBR SYSTEM (K073502)Vertebron, Inc.2008-03-24
BONE FIXATION WIRE (KIRSCHNER WIRE) (K073674)Signal Medical Corp.2008-03-24
MODELS TENS 7000, EMS 7500 AND TWIN STIM (K080661)Koalaty Products, Inc.2008-03-24
VIRTUAL PORTS ENDOCLEAR SYSTEM (K080051)Virtual Ports, Ltd.2008-03-21
SURGISIS BIODESIGN TISSUE GRAFT (K073391)Cook Biotech, Inc.2008-03-21
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE (K080680)Surgical Specialties Corp2008-03-21
NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) (K072406)Sgmp Co., Ltd.2008-03-21
MANDREL GUIDEWIRES OR M-WIRE (K080508)Lake Region Medical2008-03-21
M5 DIAGNOSTIC ULTRASOUND SYSTEM (K080640)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2008-03-21
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM (K072369)Hmd Biomedical, LLC2008-03-21
JIERUI SYRINGES AND NEEDLES (K072739)Shandong Weigao Group Medical Polymer Co., Ltd.2008-03-21
ZIEHM VISION 2 (K073346)Ziehm Imaging, Inc.2008-03-21
COBAS LITHIUM (K063684)Roche Diagnostics Corp.2008-03-21
AAP BONE PLATES AND SCREW IMPLANTS (K072411)Aap Implantate AG2008-03-20
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