Atlas FDA

2011

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

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RecordFirmDate
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K103182)Genoray Co., Ltd.2011-01-14
84E SERIES SINGLE PLY WRAPPER (K102864)Lac Mac, Ltd.2011-01-14
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 (K092963)Genx Intl., Inc.2011-01-14
AUDIT MICROCV PROTEIN LINEARITY SET (K101216)Aalto Scientific, Ltd.2011-01-14
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM (K102077)Cma Microdialysis AB2011-01-14
PROLYTE ELECTROLYTE ANALYZER (K102959)Diamond Diagnostics, Inc.2011-01-14
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER (K103353)Navilyst Medical, Inc.2011-01-14
IMC HYPODERMIC NEEDLE (K102584)International Medsurg Connection2011-01-14
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ (K103032)Olympus Winter & Ibe GmbH2011-01-14
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 (K100829)Medica Corp.2011-01-14
INFRARED EAR THERMOMETER, MODEL IR-04MT (K102934)Vega Technologies, Inc.2011-01-14
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, (K102432)Diazyme Laboratories2011-01-14
AHWON'S IPL SYSTEM (K102857)Ahwon Medi Instrument Co., Ltd.2011-01-14
KING COBRA ANTERIOR CERVICAL PLATE (K103068)Eminent Spine2011-01-14
PLATELIA ASPERGILLUS EIA MODEL 62793 (K093678)Bio-Rad2011-01-13
CASPIAN SPINAL SYSTEM (K103232)K2m, Inc.2011-01-13
BONASIL A+ IMPRESSION MATERIALS (K102836)Dmp, Ltd.2011-01-13
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR (K102996)Medivators Reprocessing Systems2011-01-13
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102613)Hebei Favor Plastic Co., Ltd.2011-01-13
HEM-AVERT PERIANAL STABILIZER (DEN090011)Plexus Biomedical, Inc.2011-01-13
DANA EMULATING INDICATOR (K100891)Dana Products, Inc.2011-01-13
HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 (K101614)Dm Systems, Incorporated2011-01-13
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH (K102460)Summit Medical Products, Inc.2011-01-13
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) (K102861)A Plus International, Inc.2011-01-13
FETAL MONITORS, MODELS F2 AND F3 (K102140)Edan Instruments, Inc.2011-01-13
FLEBOSET DOUBLE (K102590)Laboratorios Grifols, S.A.2011-01-13
SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 (K103652)Philips Medical Systesms2011-01-13
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM (K102915)Viewray, Incorporated2011-01-12
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A (K103365)Ge Healthcare Coils (Usa Instruments, Inc.)2011-01-12
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR (K102121)Apollo Spine, Inc.2011-01-12
BREATHSCN PRO (K102338)Akers Biosciences, Inc.2011-01-12
ISCREEN VISION SCREENER (K102651)Iscreen Vision, Inc.2011-01-12
MIXED MEDIA MARKER (K102506)Cortex Manufacturing, Inc.2011-01-12
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM (K103645)Toshiba Medical Systems Corporation, Japan2011-01-12
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + (K103070)G Surgical Co., Ltd.2011-01-12
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) (K103394)Varian Medical Systems, Oncology Systems2011-01-12
OSBONE DENTAL (K102872)Curasan AG2011-01-12
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER (K103144)Shantou Institute of Ultrasonic Instruments (Siui2011-01-12
EXPECT ENDOSCOPIC ASPIRATION NEEDLE (K110030)Boston Scientific Corp2011-01-12
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) (K102834)Kinamed, Incorporated2011-01-12
SMARTXIDE 50 HS/MS (K101904)El.En Electronic Engineering Spa2011-01-12
PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP (K103470)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.2011-01-11
CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (K103159)Cardio Medical Products, Inc.2011-01-11
EMBRYOSCOPE AND EMBRYOSLIDE (K092183)Unisense Fertilitech A/S2011-01-11
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS (K102781)Olympus Winter & Ibe GmbH2011-01-11
CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD (K101995)Oridion Capnography, Inc.2011-01-11
HVR PAIN RELIEF DEVICE (K101716)H.V.R., Inc.2011-01-11
BT-CATH (K101535)Utah Medical Products, Inc.2011-01-11
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS (K103275)Siemens Medical Solutions USA, Inc.2011-01-11
AVAMAX VERTEBRAL BALLOON (K103064)Care Fusion2011-01-10
HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE (K103046)Hosman International Co., Ltd.2011-01-10
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER (K103110)Abbott Vascular-Cardiac Therapies2011-01-10
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET (K102617)Aalto Scientific, Ltd.2011-01-10
CAMLOG VARIO SR ABUTMENTS (K103252)Altatec GmbH2011-01-10
IMPLANT-ONE SYSTEM (K102822)Custom Dental Implants, Inc.2011-01-10
ALLOFUSE PLUS (K103036)Allosource, Inc.2011-01-10
YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 (K102508)Yu Long Sheng Technology Co., Ltd.2011-01-10
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) (K103209)Nanosphere, Inc.2011-01-10
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX (K103033)Zimmer Trabecular Metal Technology2011-01-10
ELECSYS DHEA-S CALCHECK 5 (K103402)Roche Diagnostics2011-01-07
6250 ULTRASOUND SYTEMS (K103152)Esaote, S.p.A.2011-01-07
SMDIA-1000 (K101953)Southmedic, Inc.2011-01-07
STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF) (K102322)Omni Surgical, L.P.2011-01-07
RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 (K101750)Reprocessing Products Corp2011-01-07
MEDPOR CONTAIN CAN IMPLANT (K102184)Porex Surgical, Inc.2011-01-07
BACKSTOP CATHETER (K103349)Pluromed, Inc.2011-01-07
ARTHREX SWIVELOCK ANCHORS (K101823)Arthrex, Inc.2011-01-07
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K103117)Conformis, Inc.2011-01-07
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING (K103224)Hospira, Inc.2011-01-07
INTELLIVUE MX40 PATIENT MONITOR (K103646)Phillips Medical Systems2011-01-07
EVOLUTION MP TOTAL KNEE SYSTEM (K102380)Wrightmedicaltechnologyinc2011-01-07
ON CALL PLUS DIABETES MONITORING SOFTWARE (K101371)ACON Laboratories, Inc.2011-01-07
BREEZE C MODEL C (3W), BREEZE C (4W) (K102304)Afikim Electric Vehicles2011-01-07
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 (K093280)Opti Medical Systems, Inc.2011-01-07
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K103512)Hologic, Inc.2011-01-07
DISPOSABLE BLOOD PRESSURE CUFF (K102823)Wuxi Medical Instrument Factory2011-01-07
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND (K102298)Depuy Mitek, A Johnson & Johnson Company2011-01-07
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL (K101588)Apollo Spine, Inc.2011-01-07
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH (K103043)Adapta Medical, Inc.2011-01-07
CENTRAL MONITORING SYSTEM (K100358)Edan Instruments, Inc.2011-01-06
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K100577)Acclarent, Inc.2011-01-06
THE ADDITION (K102683)Ob The-Addition, LLC2011-01-06
THE GRAPPLR AND GRAPPLR EXTENDER (K101616)Tag Medical Corp.2011-01-06
BD NEXIVA CLOSED IV CATHETER SYSTEM (K102520)Becton Dickinson Infusion Therapy Systems, Inc.2011-01-06
KENZ CARDY302 MAX (K101024)Suzuken Co., Ltd.2011-01-06
CLEARVIEW EXACT II INFLUENZA A & B TEST (K103610)Alere Scarborough, Inc D/B/A Binax, Inc.2011-01-06
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) (K103168)Sorin Group Deutschland GmbH2011-01-06
NEOPOP INFANT RESUSCITATOR WITH FLOW METER (K102649)Neoforce Group, Inc.2011-01-06
NUPRO MODEL 13016901 (K103160)CAO Group, Inc.2011-01-06
PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE (K102698)Ellman Int'L, Inc.2011-01-05
BIOMED WOUND CLEANSER (K100613)Biomed Laboratories, Inc.2011-01-05
PARAMOUNT R IBF DEVICE (K103228)Theken Spine, LLC2011-01-05
ENDOBUTTON DIRECT (K102982)Smith & Nephew Inc., Endoscopy Division2011-01-05
SYNTHES 6.0 COCR AND CPT TI-3 RODS (K103287)Synthes Spine2011-01-05
CALIBER SPACER (K102293)Globus Medical, Inc.2011-01-05
SPINEANALYER MODEL SAPOC (K103475)Optasia Medical2011-01-05
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS (K102806)Allergan Medical2011-01-05
GAUNYING INFRARED LAMP MODEL IL50 (K101693)Foshan Gaunying Electronics Co., Ltd.2011-01-05
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM (K103722)Medison Co., Ltd.2011-01-05
SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY (K102544)Smith & Nephew Inc., Endoscopy Div.2011-01-05
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Every clearance here is in the API, with alerts when new ones post.