Atlas FDA

2012

3,135 FDA 510(k) clearances · Clearance year

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RecordFirmDate
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K120797)Shandong Shouguang Kingliyuan Medical Apparatus &2012-07-27
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (K113307)Hmd Biomedical, Inc.2012-07-27
MULTIPLATE 5.0 AGGREGOMETER (K103555)Verum Diagnostica GmbH2012-07-27
HC-BIOS DENTAL IMPLANT (K110425)Hung Chun Bio-S Co., Ltd.2012-07-27
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE (K120230)Shandong Taixiang Medical Products Co., Ltd.2012-07-27
THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL (K121748)Access Scientific, Inc.2012-07-27
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT (K121604)Obp Corporation2012-07-27
ENDOBEAM HOLMIUM LASER FIBERS (K120926)C.R. Bard, Inc.2012-07-27
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER (K113544)Prospera Corporation2012-07-27
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES (K121897)Cardinal Health, Inc.2012-07-27
IPS 99 ONE AND IPS 99 CERAM (K121359)Ivoclar Vivadent, AG2012-07-27
ZEOBI (K121338)Ivivi Health Science, LLC2012-07-27
ORION (K113489)Asclepion Laser Technologies GmbH2012-07-27
VEGA KNEE SYSTEM (K121879)Aesculap Implant Systems2012-07-27
MOJO, VERASEAL (K120463)Sleepnet Corporation2012-07-27
IO-TOME DEVICE (K113073)Baxano, Inc.2012-07-27
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR (K121909)Sorin Group Italia S.R.L.2012-07-26
CAREGUIDE OXIMETER (K113656)Reflectance Medical, Inc.2012-07-26
CS-SERIES-FP WITH 3030+OPTION (K121293)Omega Medical Imaging, LLC2012-07-26
FUJINON COLONOSCOPES (K112391)Fujinon, Inc.2012-07-26
MOBILE C-ARM (K121303)Canon Inc. -Medical Equipment Group2012-07-26
AQUILION RXL (K121553)Toshibamedical Systems Corporation2012-07-26
ICP TRIAGEMANAGER (K122095)Emergo Europe Consulting BV2012-07-26
E-CUBE 15 (K121888)Alpinion Medical Systems Co., Ltd.2012-07-26
BEACON STABILIZATION SYSTEM (K121922)Globus Medical, Inc.2012-07-26
NERVEVISION SOFTWARE SYSTEMS (K121075)3D Imaging Partners, Inc.2012-07-26
CONTOUR NEXT BLOOD GLUCOSE METER (K121190)Bayer Healthcare, LLC2012-07-26
E-CUBE INNO (K121937)Alpinion Medical Systems Co., Ltd.2012-07-26
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS (K121183)Biomet Corporation2012-07-26
ORIGEN REINFORCED DUAL LUMEN CATHETER (K113869)Origen Biomedical, Inc.2012-07-26
MICROTARGETING XL STAR DRIVE SYSTEM (K121950)FHC, Inc.2012-07-26
CLARISCT (K120753)Icrco, Inc.2012-07-26
WI-FI BODY SCALE (K120896)Andon Health Co, Ltd.2012-07-26
A/C ENZYMATIC VITAMIN B6 ASSAY (K111260)Anticancer, Inc.2012-07-26
CONNEX VITAL SIGNS MONITOR 6000 SERIES (K121013)Welch Allyn, Inc.2012-07-26
ALERE PBP2A TEST (K121905)Alere Scarborough, Inc.2012-07-26
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM (K113397)Zeus Scientific, Inc.2012-07-26
PIONEER STERNAL ASSIST IMPLANT SYSTEM (K120016)Pioneer Surgical Technology, Inc.2012-07-26
STRYKER ALL SUTURE ANCHORS (K120509)Stryker2012-07-26
GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER (K120993)Varian Medical Systems, Inc.2012-07-26
LDR SPINE USA AVENUE L INTERBODY FUSION (K113285)Ldr Spine USA, Inc.2012-07-26
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (K121512)Bio-Logic Systems Corp.2012-07-26
SOVEREIGN SPINAL SYSTEM (K121982)Medtronic Sofamor Danek2012-07-26
S.C.O.R.E.S. UNIT (K110898)Ammed Surgical Equipment, LLC2012-07-26
DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT (K120988)Medtronic, Inc.2012-07-25
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER (K121275)Convatec, Inc.2012-07-25
SENZZZZZ AWAY (K120176)Centrix, Inc.2012-07-25
COMPOTHIXO (K111465)Kerrhawe SA2012-07-25
HLS UNI EVOLUTION & U-KNEETEC (K120262)Tornier, Inc.2012-07-25
CLEARFIL MAJESTY FLOW (K121583)Kuraray Noritake Dental, Inc.2012-07-25
TL TRISEB CREAM (K121134)Trigen Laboratories, Inc.2012-07-25
IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER (K121510)Covidien, Formerly US Surgical A Divison of Tyco H2012-07-25
FLEXITIME FAST & SCAN LIGHT FLOW (K120914)Heraeus Kulzer, LLC2012-07-25
POSISEP AND POSISEP X HEMOSTAT DRESSINGS (K120958)Hemostasis, LLC2012-07-25
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (K120625)Roche Diagnostics2012-07-25
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER (K121195)Ninepoint Medical, Inc.2012-07-25
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST (K121557)Guangzhou Wondfo Biotech Co., Ltd.2012-07-25
SYNTHES ZERO-P VARIABLE ANGLE (VA) (K121852)Synthes Spine Co.Lp2012-07-25
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A (K120377)J. Morita USA, Inc.2012-07-25
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K121252)Stryker Corp.2012-07-25
SAFETY INFUSION SET (K121908)Greiner Bio-One North America, Inc.2012-07-25
E1 EAR SENSORS (K121912)Masimo Corporation2012-07-24
O2PAK OXYGEN GENERATOR (K120566)Pacific Precision Products2012-07-24
COMPRESSION CARE FLIGHT (K121376)Medical Minds, LLC2012-07-24
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 (K113546)Roche Diagnostics2012-07-24
MICROLUX/DL MICROLUX/BLU BIO/SCREEN (K121282)Addent, Inc.2012-07-24
CONE-TROL LIQUID CHEMISTRY CONTROLS (K121759)Cone Bioproducts2012-07-24
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR (K121907)Siemens Healthcare Diagnostics2012-07-23
NIO 5MP (K121788)Barco N.V.2012-07-23
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY (K121229)Sorin Group Italia S.R.L.2012-07-23
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) (K121658)Orthofix, Inc.2012-07-20
CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) (K121441)Bovie Medical Corporation2012-07-20
SLIDEWIRETM(TRADEMARK PENDING) (K113162)Acme-Monaco Corp.2012-07-20
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING (K113229)C.R. Bard, Inc.2012-07-20
Z6 DIAGNOSTIC ULTRASOUND SYSTEM (K122010)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-07-20
GMK SPHERE (K121416)Medacta International2012-07-20
DISPOSABLE TORQUE DEVICE (K113498)Coeur, Inc.2012-07-20
GEMORE TENS SYSTEM (K120569)Gemore Technology Co, Ltd.2012-07-20
HYBRID ARCTICGEL PAD (K120849)Medivance, Inc.2012-07-20
VERSAVUE ENTERPRISE SUITE (K121517)Icad, Inc.2012-07-20
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER (K121159)Integra Lifescience Corportation2012-07-20
SURGICASE CONNECT, SURGICASE GUIDE (K112389)Materialise NV2012-07-20
CR 10-X DIGITIZER (K121948)Agfa Healthcare N.V.2012-07-20
CASIAN, 3.5/4.5 CONNECTORS (K121808)K2m, Inc.2012-07-20
DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE (K121835)Encore Medical L.P.2012-07-20
NOVACATH SECURE IV CATHETER SYSTEM-18G (K120839)Tangent Medical Technologies, Inc.2012-07-20
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (K121612)American Medical Systems2012-07-20
CFR QUANT (K113754)University of Texas Medical School AT Houston2012-07-19
BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE (K111401)Hangzhou Bever Medical Devices Co., Ltd.2012-07-19
HANDHELD ECG MONITOR (K112622)Beijing Choice Electronic Technololgy Co., Ltd.2012-07-19
CORPATH 200 SYSTEM (K120834)Corindus, Inc.2012-07-19
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) (K120970)Tangshan Zhonghong Pulin Plastic Co.,Ltd2012-07-19
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM (K121270)Bioject Medical Technologies, Inc.2012-07-19
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) (K121868)Hologic, Inc.2012-07-19
CONTINUOUS SINGLE CULTURE COMPLETE (K121572)Irvine Scientific Sales Co., Inc.2012-07-19
ACE ALT REAGENT (K113382)Alfa Wassermann2012-07-19
RSCRIBE ELECTROCARDIOGRAPH (K120865)Mortara Instrument, Inc.2012-07-19
PROCARE MONITOR B40 (K120598)Ge Medical Systems China Co., Ltd.2012-07-19
CAPNOSTREAM20P WITH AI/ODI (K112368)Oridion Medical 1987 , Ltd.2012-07-19
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) (K111406)Hangzhou Bever Medical Devices Co., Ltd.2012-07-19
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