Atlas FDA

2011

3,124 FDA 510(k) clearances · Clearance year

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RecordFirmDate
21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) (K112604)Totoku Electric Co., Ltd.2011-10-27
ZOLL RESCUENETLINK (K111296)Zoll Medical Corporation, World Wide Headquarters2011-10-27
TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER (K112529)Advanced Instrumentations, Inc.2011-10-27
CLEARSPLINT ES (K111828)Astron Dental Corporation2011-10-26
US-101L, US-103S (K112520)Ito Co., Ltd.2011-10-26
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM (K112174)Zimmer, Inc.2011-10-26
EXPEDIUM SPINE SYSTEM (K110551)Johnson & Johnson2011-10-26
SYNTHES STERNAL FIXATION SYSTEM (K112689)Synthes, Inc.2011-10-26
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM (K111512)Thompson Mis, Inc.2011-10-26
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH (K111822)Diagnostica Stago, Inc.2011-10-26
VITEK 2 STREPTOCOCCUS PENICILLIN (K112000)bioMerieux, Inc.2011-10-26
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS (K111621)Masimo Corporation2011-10-26
IPC POWEREASE SYSTEM (K111520)Medtronic Xomed, Inc.2011-10-26
MULTI-ANALYTE DETECTION SYSTEMS (K112810)Bio-Rad Laboratories2011-10-26
AFFIRM (TM) VCF SYSTEM (K110998)Algea Therapies2011-10-25
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS (K111825)Covidien, Formerly US Surgical A Divison of Tyco H2011-10-25
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS (K112192)Bausch & Lomb, Inc.2011-10-25
REVIVE INTERMEDIATE CATHETER (REVIVE IC) (K112828)Codman & Shurtleff, Inc.2011-10-25
VUSION(R) OS (K111965)Ortho Development2011-10-25
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM (K102454)Respironics Respiratory Drug Delivery (Uk) , Ltd.2011-10-25
CHARGER BALLOON DILATATION CATHETER (K112701)Boston Scientific2011-10-25
HEALIX KNOTLESS(TM) ANCHOR (K112249)Depuy Mitek, A Johnson & Johnson Company2011-10-25
AMS ELEVATE PC (K112842)American Medical Systems, Inc.2011-10-25
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF (K112786)Synovis Orthopedic and Woundcare, Inc.2011-10-25
SKAFFOLD CIS (K111538)Skeletal Kinetics, LLC2011-10-25
PATIENT MONITOR (K112803)Guangdong Biolight Meditech Co., Ltd.2011-10-24
SOFIA ANALYZER AND INFLUENZA A+B FIA (K112177)Quidel Corp.2011-10-24
NANOKNIFE SYSTEM (K102329)AngioDynamics, Inc.2011-10-24
WINGEATER V2 (K111948)JMS North America Corporation2011-10-24
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT (K112497)C.R. Bard, Inc.2011-10-24
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES (K102387)Mediscope Manufacturing, Inc.2011-10-24
FRAMEWALKER (K111993)Quantum Medical Concepts, LLC2011-10-24
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (K110569)Inovise Medical, Inc.2011-10-24
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE (K110783)L&K BIOMED Co., Ltd.2011-10-24
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA (K103513)Advanced Orthopaedic Solutions, Inc.2011-10-24
DIOSLIMON IMPLANT SYSTEM (K112746)Dio Corporation2011-10-21
LIFECARE ARM & LEG PAIN RELIEF SYSTEM (K112415)Everyway Medical Instruments Co.,Ltd2011-10-21
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM (K111030)Intromedic Co., Ltd.2011-10-21
CD HORIZON SPINAL SYSTEM (K112473)Medtronic Sofamor Danek, Inc.2011-10-21
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER (K111854)St. Jude Medical Systems AB2011-10-21
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER (K112292)Stryker Sustainability Solutions2011-10-21
ENSPIRE DEBRIDER SYSTEM (K110992)Spine View, Inc.2011-10-21
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE (K112166)W and R Investments Dba Laser Engineering2011-10-21
PHYSIOGLOVE ES WITH ECG ANALYSIS (K103791)Commwell , Ltd.2011-10-21
VRESELECT CULTURE MEDIUM (K103684)Bio-Rad2011-10-21
FRESENIUS 2008T HEMODIALYSIS MACHINE (K111639)Fresenius Medical Care2011-10-21
VIZION DR (K112661)Viztek, LLC2011-10-20
DIGIVIEW 250 (K103348)Kub Technologies, Inc.2011-10-20
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE (K111772)Kossan Latex Industries(M)Sdn Bhd2011-10-20
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 (K101286)Linde Healthcare AB2011-10-20
DELTEX MEDICAL CARDIOQ EDM (K111542)Deltex Medical Limited2011-10-20
XTRAFIX EXTERNAL FIXATION SYSTEM (K111155)Extraortho, Inc.2011-10-20
THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE (K112468)Regulatory Specialists, Inc.2011-10-20
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE (K112269)OSTAR MEDITECH CORP.2011-10-20
X-TRA BASE (K112374)Voco GmbH2011-10-20
NEUROLAC(R) NERVE GUIDE (K112267)Polyganics B.V.,2011-10-20
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE (K110315)Nexgen Medical Systems, Inc.2011-10-20
EASTLYTE NA/K/CA/PH (K112788)Medica Corp.2011-10-20
QUADRA BLOC TENS PLUS (K102278)Gradient Technologies, LLC2011-10-20
ALERKAN SPIROMETRY FILTER (K111587)Alerkan, Ltd.2011-10-20
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN (K110432)Affinity Biologicals, Inc.2011-10-20
SAPIENS TIP CONFIRMATION SYSTEM (K112744)C.R. Bard, Inc.2011-10-20
SYNTHES XRL (K103320)Synthes Spine Co.Lp2011-10-20
BD GENEOHM VANR ASSAY (K102416)Bd Diagnostics Science2011-10-20
DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS (K110979)Advanced Medical Products Sdn Bhd2011-10-20
LIPSONIX(R) SYSTEM MODEL 2 (K112626)Medicis Technologies Corporation2011-10-20
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL (K111402)Kimberly-Clark2011-10-20
CARESTREAM PACS (K110919)Carestream Health, Inc.2011-10-20
DURA BLUE STERILIZATION WRAP (K112283)Cardinal Health200, LLC2011-10-20
TIGER HEADLESS CANNULATED SCREWS (K112737)Trilliant Surgical, Ltd.2011-10-20
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K112974)Curve Dental, Inc.2011-10-20
QUANTA FLASH (TM) DGP SCREEN (K111414)Inova Diagnostics, Inc.2011-10-20
SMART TOUCH UVTHERAPY MULTIPLE MACHINE (K110912)Daavlin Distributing Co.2011-10-20
VANISHPOINT BLOOD COLLECTION SET (K112512)Retractable Technologies, Inc.2011-10-20
DURA BLUE STERILIZATION WRAP (K112211)Cardinal Health200, LLC2011-10-20
SCANVIEW SYSTEM (K110345)Applied Spectral Imaging2011-10-19
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS (K111766)Idev Technologies, Inc.2011-10-19
AMT G-J TUBE (K110804)Applied Medical Technology, Inc.2011-10-19
TBD (K112098)Lensar, Inc.2011-10-19
DASH HIP (K110021)Brainlab AG2011-10-18
V-14 CONTROL WIRE GUIDEWIRE (K112745)Boston Scientific Corporation2011-10-18
THERMOFLASH(TM) INFRARED THERMOMETER (K112929)Visiomed Group SA2011-10-18
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) (K112586)Becton, Dickinson and Company (BD)2011-10-18
RADIOACTIVE SEED LOCALIZATION NEEDLE (K111979)Biocompatibles, Inc.2011-10-18
ABDOMINAL TOURNIQUET SYSTEM (K112384)Compression Works, LLC2011-10-18
APCLO PEDICLE SCREW SYSTEMS (K112759)Atlas Spine, Inc.2011-10-18
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN (K111904)Ark Diagnostics, Inc.2011-10-18
ELECSYS T4 CALCHECK 5 (K112528)Roche Diagnostics Corporation2011-10-18
SMARTLOC SPINAL FIXATION SYSTEM (K111883)A-Spine Asia, Co., Ltd.2011-10-18
EVERYWAY LOW BACK PAIN RELIEF SYSTEM (K110716)Everyway Medical Instruments Co.,Ltd2011-10-18
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS (K112893)Baxter Healthcare Corporation2011-10-18
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE (K111909)bioMerieux, Inc.2011-10-18
CARDIA-CATH (K112323)Millar Instruments, Inc.2011-10-18
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 (K112439)Fujifilm Medical System U.S.A., Inc.2011-10-17
ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR (K112710)Wieland Dental + Technik GmbH & Co. KG2011-10-17
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM (K112156)Medos International SARL2011-10-17
EZ VEIN INFLATABLE TOURNIQUET (K112874)Dominion Medical Devices, LLC2011-10-17
8FR TURBO - TANDEM SYSTEM (K112032)Spectranetics Corp.2011-10-17
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) (K111354)GS Medical Co., Ltd.2011-10-17
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES (K103598)Wrightmedicaltechnologyinc2011-10-17
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Every clearance here is in the API, with alerts when new ones post.