Atlas FDA

2003

3,516 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR (K032676)Ethicon Endo-Surgery, Inc.2003-10-30
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 (K030082)Richard Wolf Medical Instruments Corp.2003-10-30
GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X (K032656)Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc2003-10-30
ENSITE SYSTEM (K033211)Endocardial Solutions, Inc.2003-10-30
HANDIVIPP (K033125)Handinor USA, Inc.2003-10-30
DBB-05 HEMODIALYSIS DELIVERY SYSTEM (K023509)Davita Clinical Research (Trri)2003-10-30
DIO-DENT 10 DENTAL DIODE LASER (K031819)Msq (M2) , Ltd.2003-10-30
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 (K033016)Medtronic Neurological2003-10-30
BONESOURCE HAC FAST SETTING CEMENT (K032366)Stryker Instruments2003-10-30
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION (K032513)Ge Medical Systems Information Technologies2003-10-30
STERISIL ANTIMICROBIAL TUBING AND BOTTLE (K031681)Sterisil2003-10-30
TOPKIN WOUND DRESSING (K031684)Biomet Merck GmbH2003-10-30
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS (K033172)Candela Corp.2003-10-30
GLOBAL PRESS-FIT STEM (K032385)Global Medical Co.2003-10-30
GLYCOHEMOSURE HBA1C CONTROL (K032791)Quantimetrix Corp.2003-10-30
ADVANTAGE 4D OPTION (K032915)Ge Medical Systems, LLC2003-10-30
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 (K033131)The First Years, Inc.2003-10-30
AMSURE FOLEY CATHETER (K030120)Amsino International, Inc.2003-10-29
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR (K032084)Shen Wei (Usa), Inc.2003-10-29
XTRAK SUPPORT CATHETER (K032660)Xtrak Medical, Inc.2003-10-29
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326)Philips Medical Systems, Inc.2003-10-29
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM (K033126)Behavioral Technology, Inc.2003-10-29
SUPEROPEN 0.23T, MODEL NAM-P023A (K033315)Neusoft Digital Medical Systems Co., Ltd.2003-10-29
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES (K023000)Home Care Technology Co., Ltd.2003-10-29
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE (K032962)Arrow Intl., Inc.2003-10-29
STICK FLOW (K031341)Stick Tech , Ltd.2003-10-29
TRIVEX SYSTEM (K032387)Smith & Nephew, Inc.2003-10-29
MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM (K032599)Medical Laser Technologies, LLC2003-10-29
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II (K032442)KLS-Martin L.P.2003-10-29
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES (K033065)Synthes (Usa)2003-10-29
SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 (K033088)Sectra AB2003-10-29
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K032024)Shen Wei (Usa), Inc.2003-10-29
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM (K033311)Aloka Co., Ltd.2003-10-29
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P (K033140)Everyway Medical Instruments Co.,Ltd2003-10-29
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE (K033078)Datex-Ohmeda2003-10-29
GIVEN DIAGNOSTIC SYSTEM (K032405)Given Imaging , Ltd.2003-10-29
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE (K032748)Vital Images, Inc.2003-10-29
PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS (K032119)Paragon Medical, Inc.2003-10-29
KAVO EVEREST ZH-BLANK (K033221)Kavo America Corporation2003-10-28
ORTRAUTEK ORTHOGNATHIC SYSTEM (K031989)Tekka2003-10-28
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS (K032356)Nxstage Medical, Inc.2003-10-28
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310 (K032484)Medtronic Minimed2003-10-28
BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN (K033295)Novamin Technology, Inc.2003-10-28
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313 (K032485)Medtronic Minimed2003-10-28
EMBLA N7000 (K024322)Medcare Flaga2003-10-27
SWISS MASTER LIGHT (K032099)(Ems Sa) Electro Medical Systems2003-10-27
SMARTMONITOR 2 PROFESSIONAL SERIES (PS) (K032403)Respironics, Inc.2003-10-27
PERFADEX SOLUTION FOR LUNG PRESERVATION (K022730)Vitrolife AB2003-10-27
FLUID SAMPLE RETRIEVAL SYSTEM (K030394)Biomed Personal Metabolic and Nutritional Testing2003-10-27
CENTRA VIEW DEVICE LINK SYSTEM (K033283)Icu Datasystems, Inc.2003-10-27
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER (K033108)Vivosonic, Inc.2003-10-27
ADEPT 1064/755 LASER (K032221)Adept Medical Concepts2003-10-24
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) (K031928)Braun GmbH2003-10-24
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER (K031503)Avita Corporation2003-10-24
ADEPT 1064/532 LASER (K032220)Adept Medical Concepts2003-10-24
CAP BONE SUBSTITUTE MATERIAL (K032307)Etex Corp.2003-10-24
ADEPT 1064/532/755 LASER (K032218)Adept Medical Concepts2003-10-24
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE (K031750)Kimberly-Clark Corp.2003-10-24
INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 (K032703)Innovatech Surgical, Inc.2003-10-24
SPR SYSTEM (K033181)Radiancy (Israel) , Ltd.2003-10-24
MODIFICATION TO SUTURE CLINCH (K033024)Applied Medical Resources Corp.2003-10-24
NASAL JACKS MASK (K032433)Resmed, Ltd.2003-10-24
INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 (K032704)Innovatech Surgical, Inc.2003-10-24
QUANTEX D-DIMER (K032419)Instrumentation Laboratory CO2003-10-24
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP (K032348)Centerpulse Orthopedics, Inc.2003-10-24
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (K032482)Stanbio Laboratory2003-10-24
DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205 (K033069)Tenghi Co., Ltd.2003-10-24
CZR PRESS (K033049)Noritake Co., Inc.2003-10-24
NUVASIVE NEUROVISION JJB SYSTEM (K032083)Nuvasive, Inc.2003-10-24
FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 (K023723)Fms, Finapres Medical Systems BV2003-10-23
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 (K032164)Medtronic Minimed2003-10-23
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM (K032530)Guidant Corporation2003-10-23
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 (K030627)C.R. Bard, Inc.2003-10-23
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K032930)Boston Scientific Corp2003-10-23
BIOPSY BREAST COIL, MODEL BBC (K032576)Mri Devices Corp.2003-10-23
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM (K032820)Ndo Surgical, Inc.2003-10-23
ELEKTA SYNERGY SYSTEM (K032996)Elekta Oncology Systems, Ltd.2003-10-23
GE MARLIN ULTRASOUND (K033139)General Electric Co.2003-10-23
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM (K030421)Alsius Corp.2003-10-23
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE (K032698)Coapt Systems, Inc.2003-10-23
ASCENSION MODULAR RADIAL HEAD (K032686)Ascension Orthopedics, Inc.2003-10-22
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED (K032374)Perusahaan Getah Asas Sdn. Bhd.2003-10-22
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS (K032559)Synthes (Usa)2003-10-22
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (K031952)Focus Technologies, Inc.2003-10-22
PARIEFIX (K032093)Sofradim Production2003-10-22
WEST NILE VIRUS ELISA IGG, MODEL EL0300G (K031953)Focus Technologies, Inc.2003-10-22
PTA BALLOON CATHETER (K032931)Cook, Inc.2003-10-22
CARDICARE MODEL MT-301F & MT-301C (K032714)Lumiscope Co., Inc.2003-10-22
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) (K032590)MicroVention, Inc.2003-10-22
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 (K032929)Abbott Vascular, Inc.2003-10-22
FORTE GAMMA CAMERA SYSTEM (K033254)Adac Laboratories2003-10-22
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES (K032726)Zimmer, Inc.2003-10-22
GE LOGIQ BOOK (K032477)General Electric Co.2003-10-22
T2 NAILING SYSTEM (K032523)Howmedica Osteonics Corp.2003-10-22
REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH (K032632)Estech, Inc.2003-10-22
RAPHAEL (K022679)Hamilton Medical AG2003-10-22
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE (K032941)Rich-Mar Corp.2003-10-22
ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE (K023139)Van Oostveen Medical B.V.2003-10-22
MEDI-HEAT INFANT HEEL WARMER (K032989)Mediheat, Inc.2003-10-22
TARAS THREADED FIXATION PIN (K032532)Union Surgical, LLC2003-10-22
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Every clearance here is in the API, with alerts when new ones post.