Atlas FDA

2014

3,202 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TRITIUM STERNAL CABLE PLATE SYSTEM (K133785)Pioneer Surgical Technology, Inc.2014-01-27
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE (K132300)Applied Medical Resources Corp.2014-01-24
MACY CATHETER (K133881)Hospi Corporation2014-01-24
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK (K133642)Biophor Diagnostics, Inc.2014-01-24
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE (K133013)Inventis S.R.L.2014-01-24
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES (K133987)Boston Scientific Corporation2014-01-24
PUREGRAFT 50 SYSTEM (K132815)Cytori Therapeutics, Inc.2014-01-24
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 (K132782)Biosense Webster, Inc.2014-01-24
KIVA VCF TREATMENT SYSTEM (K132817)Benvenue Medical, Inc.2014-01-24
FETAL ULTRASONIC MONITOR AND ACCESSORIES (K131457)Shenzhen Jumper Medical Equipment Co., Ltd.2014-01-24
ADD-VANTAGE ADDAPTOR (K133602)Hospira, Inc.2014-01-24
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K133728)Siemens Healthcare Diagnostics, Inc.2014-01-24
DYNATRON PELTIER THERMOSTIM PROBE (K132057)Dynatronics Corp.2014-01-24
MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE (K133726)Megadyne Medical Products, Inc.2014-01-24
ATRICURE CRYO MODULE SYSTEM (K140058)AtriCure, Inc.2014-01-24
EPAD (K132616)Safeop Surgical, Inc.2014-01-24
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR (K131307)Siemens Healthcare Diagnostics, Inc.2014-01-24
YSIO MAX (K133259)Siemens Medical Solutions USA, Inc.2014-01-24
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS (K131500)Aesculap, Inc.2014-01-24
MPP (K131910)Marc Pro2014-01-24
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE (K132928)Medrad, Inc. / Bayer Medical Care, Inc.2014-01-23
KHAN KINETIC TREATMENT (KKT-M2) (K130666)Optima Health Solutions International Corporation2014-01-23
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K131490)Ellipse Technologies, Inc.2014-01-23
SPEED 808 DIODE LASER SYSTEM (K132989)Beijing Toplaser Technology Co., Ltd.2014-01-23
ZYNO MEDICAL ADMINISTRATION SET (K132841)Zyno Medical, LLC2014-01-23
JUVORA DENTQAL DISC (K132725)Juvora2014-01-23
GRINDGUARD (K133037)Grind Guard Technologies, LLC2014-01-23
CAREFINE PEN NEEDLE (K133100)Facet Technologies2014-01-23
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 (K133675)Aap Implantate AG2014-01-23
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 (K131580)Tosoh Bioscience, Inc.2014-01-23
MAC 2000 ECG ANALYSIS SYSTEM (K133622)Wipro GE Healthcare2014-01-23
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) (K132722)Instrumentation Laboratory CO2014-01-22
REPROCESSED CLOSURE SYSTEM (K133414)Sterilmed, Inc.2014-01-22
KESTREL POSTERIOR CERVICAL SPINE SYSTEM (K132122)Omni Surgical, LLC Dba Spine3602014-01-22
ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY (K133938)Covidien2014-01-22
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) (K133950)Bioretec, Ltd.2014-01-22
HYPERION LONG PULSED ND: YAG LASER (K132286)Scarlet Rf, Inc.2014-01-22
CO2 FRACTIONAL LASER (K131837)Beijing Honkon Technologies Co., Ltd.2014-01-22
MPACT EXTENSION (K132879)Medacta International2014-01-22
ZOE FLUID STATUS MONITOR (K133301)Noninvasive Medical Technologies, Inc.2014-01-22
VSP SYSTEM (K133907)Medical Modeling, Inc.2014-01-22
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152)Stanmore Implants Worldwide , Ltd.2014-01-22
DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) (K133030)Invivo Corporation2014-01-22
EDS ULTRASONIC TIPS (K132609)Essential Dental Systems, Inc.2014-01-22
CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM (K130613)Laura Cattabriga2014-01-22
AESCULAP PEEK XP SPINAL IMPLANT SYSTEM (K132421)Aesculap Implant Systems, Inc.2014-01-22
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS (K131135)Biomet Manufacturing Corp2014-01-22
ANKYLOS SYNCONE ABUTMENT 5(DEGREE) (K131644)Dentsply International, Inc.2014-01-22
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL (K133960)Bio-Rad Laboratories2014-01-22
MOTION WATCH AND PRO-DIARY (K132764)Camntech, Ltd.2014-01-21
ICRCO CLARITY VIEWER (K132499)Icrco, Inc.2014-01-21
A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM (K132125)A.B. Dental Devices , Ltd.2014-01-21
PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA (K132682)Atheromed, Inc.2014-01-17
IOB DISPOSABLE SPECULUM (K132668)Iob Medical, Inc.2014-01-17
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT (K133869)Center For Disease Control and Prevention (Cdc)2014-01-17
INJECTION NEEDLE (K132065)Endochoice, Inc.2014-01-17
GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM (K123517)Sd Biosensor2014-01-17
ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM (K133228)Iconacy Orthopedic Implants, LLC2014-01-17
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR (K133375)Banyan Medical, LLC2014-01-17
OREGON SCINTIFIC (K131245)Idt Technology Limited2014-01-17
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE (K133197)Fujirebio Diagnostics,Inc.2014-01-17
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM (K133833)Philips Ultrasound, Inc.2014-01-17
BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS (K130614)Laura Cattabriga2014-01-17
SMARTDOP XT (K131623)Koven Technology, Inc.2014-01-17
GALAXY PLUS (K132921)Medien International Co, Ltd.2014-01-17
XARIO 100 (K133277)Toshibamedical Systems Corporation2014-01-17
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA (K133875)Ortho Kinematics, Inc.2014-01-17
SUPRAPUBIC CATHETER AND INTRODUCER SET (K132890)Mediplus , Ltd.2014-01-17
MODIFIED TREVO PROVUE RETRIEVER (K133464)Concentric Medical, Inc.2014-01-17
CYTOSCAN(R) DX (DEN130018)Affymetrix, Inc.2014-01-17
APOLLO SYSTEM (K132931)Penumbra, Inc.2014-01-17
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W (K132410)Ge Medical Systems, LLC2014-01-17
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 (K133424)Siemens Medical Solutions USA, Inc.2014-01-17
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY (K131168)Immunalysis Corporation2014-01-17
Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU (K133727)ArthroCare Corporation2014-01-16
DOLPHIX EXTERNAL FIXATION SYSTEM (K132363)Citieffe S.R.L.2014-01-16
SYNAPSE SYSTEM (K133698)Synthes USA Products, LLC2014-01-16
Q-SWITCHED ND:YAG LASER (K131857)Beijing Honkon Technologies Co., Ltd.2014-01-16
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130732)Aide Plastic Co., Ltd.2014-01-16
DYNESYS TOP-LOADING SPINAL SYSTEM (K133164)Zimmer Spine, Inc.2014-01-16
HEM-7311 (K133379)Omron Healthcare, Inc.2014-01-16
OPTIO-C ANTERIOR CERVICAL SYSTEM (K132894)Zimmer Spine, Inc.2014-01-16
QUICKNIT (K131799)Microcopy, Div. of Neo-Flo, Inc.2014-01-16
ENDOCENTER (K131151)Satelec - Acteon Group2014-01-16
CALPREST (K130945)Eurospital S.P.A.2014-01-16
POWERGLIDE MIDLINE CATHETER (K133856)C.R. Bard, Inc.2014-01-16
STARLIGHT (K133250)Orthomerica Products, Inc.2014-01-16
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES (K132528)GE Healthcare Finland Oy2014-01-16
COMPUTED RADIOGRAPHY SCANNER (K133120)3Disc Americas2014-01-15
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES (K132844)Straumann USA, LLC2014-01-15
BIOPHOTAS CELLUMA (K131113)Biophotas, Inc.2014-01-15
ILUMINAGE SKIN SMOOTHING LASER (K133473)Cynosure, Inc.2014-01-15
COMPUTED RADIOGRAPHY SCANNER (K133106)3Disc Americas2014-01-15
ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD (K131110)Co-Innovation Biotech Co., Ltd.2014-01-15
U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT (K131864)United Orthopedic Corporation2014-01-15
COSENSE CO MONITOR (K130036)Capnia, Inc.2014-01-14
SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA (K133499)Suzhou Beinuo Medical Equipment Co. , Ltd.2014-01-14
TIGER SPINE SYSTEM (K133369)Corelink, LLC2014-01-14
TASMIN R (K123758)Signus Medizintechnik GmbH2014-01-14
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL (K132739)Siemens Healthcare Diagnostics, Inc.2014-01-14
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