Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
RAYSTATION VERSION 1.0 (K100552)Raysearch Laboratories AB2010-03-12
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES (K093213)Carl Zeiss Meditec, Inc.2010-03-12
LIQUICHEK OPIATE CONTROL (K093577)Bio-Rad Laboratories2010-03-12
DIAGNOSOFT HARP MODEL 2.06 (K100352)Diagnosoft, Inc.2010-03-11
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS (K092474)K2m, Inc.2010-03-11
CARESTREAM IMAGE SUITE (K100094)Carestream Heatlh, Inc.2010-03-11
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 (K092980)Panpac Medical Corporation2010-03-11
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION (K092847)Covidien, Formerly Nellcor Puritan Bennett, Inc.2010-03-11
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (K092181)Instrumentation Laboratory CO2010-03-11
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K093936)Spineart2010-03-11
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (K091656)Organ Recovery Systems, Inc.2010-03-11
SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K092852)St. shine Optical Co., Ltd.2010-03-11
IGUIDE CAPPA (K093787)Cas Innovations GmbH & Co. KG2010-03-11
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX (K093864)Stryker Corp.2010-03-11
WELL LEAD ENDOBRONCHIAL TUBES (K092886)Well Lead Instruments2010-03-11
INTEGRATED LABORATORY AUTOMATION SOLUTION (K091975)Integrated Laboratory Automation Solutions, Inc.2010-03-10
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK (K100506)Teleflex Medical2010-03-10
PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 (K093124)Cardinal Health 207, Inc.2010-03-10
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER (K092409)Intersurgical, Inc.2010-03-10
OLYMPUS CHF TYPE Y0003 (K093507)Olympus Medical Systems Corporation2010-03-10
EXCITE F AND EXCITE DSC (K093744)Ivoclar Vivadent, Inc.2010-03-10
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM (K092414)Conmed Corporation2010-03-10
MATTIOLI PULSE TWO/THREE PLUS FAMILY (K100053)Mattioli Engineering Corp.2010-03-10
FIXIT HEADREST CLAMP SYSTEM (K083803)Medicon EG2010-03-10
ENDOCLEAR SYSTEM (K100346)Virtual Ports, Ltd.2010-03-10
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D (K093526)Kci USA, Inc. (Kinetic Concepts, Inc.)2010-03-10
CLARUJUST (K092089)Audigence, Inc.2010-03-10
BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 (K092383)Bovie Medical Corporation2010-03-10
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) (K093384)Diamond Diagnostics, Inc.2010-03-10
TC PLATING SYSTEM (K094037)Ortho-Pro, LLC2010-03-10
INBODY, MODELS: 270, R20, R20B (K092786)Biospace Corporation Limited2010-03-10
XVI R4.5 (K100115)Elekta , Ltd.2010-03-10
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED (K092930)Nexus Medical, LLC2010-03-10
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K092545)Ino Therapeutics, LLC2010-03-10
AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS (K093773)Amsino International, Inc.2010-03-10
NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO (K092908)Neomed, Inc.2010-03-10
TELIO CAD (K093708)Ivoclar Vivadent, Inc.2010-03-10
PULPDENT FLUORIDE VARNISH (K093620)Pulpdent Corporation2010-03-10
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH (K092141)3M Espe Dental Products2010-03-10
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA (K091520)Immco Diagnostics, Inc.2010-03-10
VERSEO AIR PRESSURE MASSAGER (K092435)The American Export Group & International Services2010-03-09
PSL CLASSIC SLIT LAMP (K100500)Keeler Instruments, Inc.2010-03-09
E1 ANTIOXIDANT INFUSED TECHNOLOGY (K100048)Biomet Manufacturing Corp2010-03-09
CLEARPATH UGI (K093779)Easyglide , Ltd.2010-03-09
POC-AS10 AUTO SAMPLER (K092817)Otsuka Pharmaceutical Co., Ltd.2010-03-09
SYNTHES MATRIX MIS RODS (K093668)Synthes (Usa)2010-03-09
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES (K082855)Menicon Co, Ltd.2010-03-09
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM (K093629)Biomet Spine2010-03-09
DX SERIES FINGER SENSOR (K100020)Dixtal Medical, Inc.2010-03-08
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION (K093788)Draeger Medical Systems, Inc.2010-03-08
MICROCYN SKIN AND WOUND HYDROGEL (K093585)Oculus Innovative Sciences, Inc.2010-03-08
DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR (K092907)Shantou Institute of Ultrasonic Instuments2010-03-05
STEREOS WORKSTATION (K090050)Biospace Med2010-03-05
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 (K092740)Abbott Laboratories2010-03-05
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 (K094017)Omni Life Science, Inc.2010-03-05
CHESAPEAKE SPINAL SYSTEM (K092211)K2m, Inc.2010-03-05
REFINE SUPPORT SYSTEM, MODEL 100.0100 (K092538)Alure Medical, Inc.2010-03-05
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM (K093336)Medical Numerics, Inc.2010-03-05
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM (K093943)Smith & Nephew Inc., Endoscopy Div.2010-03-05
EMPI CONTINUUM (K093324)Empi2010-03-05
SITE-RITE VISION ULTRASOUND SYSTEM (K100402)Bard Access Systems, Inc.2010-03-05
ACUITY BREAK-AWAY GUIDE CATHETER (K093969)Cardiac Pacemakers, Inc.2010-03-05
SMOOTHCOOL (K092326)Jeisys Medical, Inc.2010-03-05
CLEARFIL MAJETY POSTERIOR (K100328)Kuraray Medical, Inc.2010-03-05
CUATTRO UNOMD (K093480)Cuattro, LLC2010-03-05
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS (K093842)Invivo Corporation2010-03-05
NEONATAL BIOTINIDASE KIT, MODEL 3018 (K090123)Perkinelmer, Inc.2010-03-05
STRYKER ARTHROSCOPE (K093677)Stryker Endoscopy2010-03-05
MIZZY EXPRESS (K093380)Mycone Dental Supply Co., Inc.2010-03-05
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K100058)Tangshan Zhongpu Plastic Products Co., Ltd.2010-03-05
CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE (K100446)Devon Medical, Inc.2010-03-05
OPTISCAN MODEL OPTISCAN CEIS (K093624)Optiscan Pty. , Ltd.2010-03-05
OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM (K093761)Biomet Trauma (Aka Ebi, Lp)2010-03-05
P-ART, MODEL 001 (K092424)P-Cure, Ltd.2010-03-05
THERATEST EL-ANTI-CCP/2 (K090753)Theratest Laboratories, Inc.2010-03-05
GLUMA DESENSITIZER POWER GEL (K093575)Heraeus Kulzer, LLC2010-03-05
COAGUCHEK XS PLUS PST SYSTEM (K092940)Roche Diagnostics Corp.2010-03-05
STAR-LITE -LM, MODEL SL8809 (K092460)Ps Advanced Engineering2010-03-05
EXL ANEM CAL, MODEL RC640 (K093645)Siemens Healthcare Diagnostics2010-03-05
AQUALASE CAPSULE WASH TIP (K093210)Alcon Manufacturing, Ltd.2010-03-04
RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR (K093576)Jiangsu Cureguard Glove Co., Ltd.2010-03-04
SPI DENTAL IMPLANT, ELEMENT (K093615)Thommen Medical AG2010-03-04
MICRO-TOUCH NITRILE (K093523)Ansell Healthcare Products, LLC2010-03-04
AUTOSTART BURETTE (K092905)Analytica Pty, Ltd.2010-03-04
SYNGO.PLAZA (K093612)Siemens AG Medical Solutions2010-03-04
SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR (K093897)Smith & Nephew Inc., Endoscopy Div.2010-03-04
SINGLE-PATIENT USE DISPOSABLE SENSOR (K093306)Nonin Medical, Inc.2010-03-04
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE (K092366)Thermal Therapeutic Systems, Inc.2010-03-04
VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS (K092857)Whip-Mix Corp.2010-03-04
VRLXP, MODEL XP (K091732)Deep Breeze , Ltd.2010-03-04
HAMILTON-C2 (K092148)Hamilton Medical AG2010-03-04
SMART CAPNOLINE GUARDIAN (K093388)Oridion Medical 1987 , Ltd.2010-03-04
EVOLUTION MP TOTAL KNEE SYSTEM (K093552)Wrightmedicaltechnologyinc2010-03-04
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) (K093508)Womancare Global2010-03-04
REPROCESSED ULTRASONIC COAGULATING SHEARS (K093702)Ascent Healthcare Solutions2010-03-04
TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET (K093127)Zimmer Trabecular Metal Technology2010-03-04
AESCULAP HYDROLIFT VBR SYSTEM (K083186)Aesculap Implant System, Inc.2010-03-04
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 (K100016)Avita Corporation2010-03-04
ELECSYS HCG STAT CALCHECK 5 (K093700)Roche Diagnostics Corp.2010-03-04
PASS LP SPINAL SYSTEM (K100297)Medicrea Technologies2010-03-04
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Every clearance here is in the API, with alerts when new ones post.