Atlas FDA

2010

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

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RecordFirmDate
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100294)Zibo Yinghao Medical Products Co., Ltd.2010-05-14
SUREFIT DUAL DISPERSIVE ELECTRODE (K100047)Conmed Corporation2010-05-14
COCR RODS (K100788)Globus Medical, Inc.2010-05-14
MRI PATIENT POSITIONING DEVICES (K093738)Medtec, Inc.2010-05-14
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES (K100271)Howmedica Osteonics Corp.2010-05-14
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS (K094046)Masimo Corporation2010-05-14
COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS (K100521)Mego Afek AC , Ltd.2010-05-14
HDL CHOLESTEROL (HDLX) ASSAY (K100010)Beckman Coulter, Inc.2010-05-14
SMART-READ EZTEST-STEAM SCBI AND TEST PACK (K093794)Sgm Biotech, Inc.2010-05-14
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE (K094054)Nuvasive, Inc.2010-05-14
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100697)Shijiazhuang Universal Channel Plastic Co., Ltd.2010-05-13
VARIAX ELBOW SYSTEM (K101056)Howmedica Osteonics Corp.2010-05-13
LENSAR LASER SYSTEM (K090633)Lensar, Inc.2010-05-13
SPINEWAND SURGICAL DEVICE (K100353)Arthrocare Corp.2010-05-13
LEGION POROUS + HA TIBIAL BASEPLATES (K100897)Smith & Nephew, Inc.2010-05-13
BABI PLUS INFANT NASAL CANNULA SYSTEM (K093716)A Plus Medical2010-05-13
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB (K093123)Biomerix Corporation2010-05-13
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, (K100433)Siemens Healthcare Diagnostics2010-05-13
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM (K100265)Amendia, Inc.2010-05-13
TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA (K092164)Shenzhen Delicate Electronics Co., Ltd.2010-05-13
SYNTHES T-PAL SPACER (K100089)Synthes Spine2010-05-13
EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 (K100560)Biotest Medical Corp.2010-05-12
PULPDENT COPAL VARNISH WITH FLUORIDE (K100503)Pulpdent Corporation2010-05-12
MINXRAY, MODEL: BPD60 (K091255)Minxray, Inc.2010-05-12
FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE (K100235)3M Company2010-05-12
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 (K100336)Eragen Biosciences2010-05-12
EASYCELL CELL LOCATOR (K092116)Medica Corp.2010-05-12
NUANCE (K101215)Discus Dental, LLC2010-05-12
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU (K092586)Innolatex (Thailand) Limited2010-05-12
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY (K093114)Microgenics Corp.2010-05-12
CAPNOSTREAM20 WITH MICROMEDICO2 MODULE (K094012)Oridion Capnography, Inc.2010-05-12
REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE (K100537)Ascent Healthcare Solutions2010-05-12
PLANMECA PROMAX 3D MAX (K093590)Planmeca Oy2010-05-12
GLIDER PTA BALLOON CATHETER (K101062)Trireme Medical, Inc.2010-05-12
THE MOSES APPLIANCE (K093710)Allen J. Moses, Dds, Ltd.2010-05-12
BWF-5 MEDICAL LASER SERIES (K093087)Litecure, LLC2010-05-12
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM (K092789)Terumo Cardiovascular Systems Corp.2010-05-12
TRILOGY 202 VENTILATOR (K093905)Respironics, Inc.2010-05-12
NAVIGATOR CLINICAL GUIDENCE SYSTEM (K092219)Applied Physiology Pty , Ltd.2010-05-12
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA (K100211)Shen Wei (Usa), Inc.2010-05-11
INTELLIVUE PATIENT MONITOR (K093268)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010-05-11
VELA VENTILATOR (K093094)Cardinal Health 207, Inc.2010-05-11
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS (K092190)Synthes (Usa)2010-05-11
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM (K093978)Exactech, Inc.2010-05-11
ZIT-Z (K092507)Ziterion2010-05-11
ACE STAPLER, MODEL F0031 (K082044)Barosense, Inc.2010-05-11
ZZOMA POSITIONAL SLEEPER MODEL 001 (K100160)Sleep Specialists, LLC2010-05-11
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES (K092812)Synthes (Usa)2010-05-11
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 (K100691)Bionix Development Corp.2010-05-11
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM (K100406)Taidoc Technology Corporation2010-05-11
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM (K100238)DePuy Orthopaedics, Inc.2010-05-11
TEMPUS IC PROFESSIONAL PATIENT MONITOR (K101264)Remote Diagnostic Technologies , Ltd.2010-05-11
AESCULAP STERILCONTAINER S (K093649)Aesculap2010-05-11
BARIREP (K100839)Gorbec Pharmaceutical Services, Inc.2010-05-11
REDSENSE-HOME USE (K092955)Redsense Medical AB2010-05-10
CLEARVIEW EXACT II INFLUENZA A & B TEST (K092349)Inverness Medical, Inc.2010-05-10
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (K101078)Bl Healthcare, Inc.2010-05-10
EPIDRUM (K093863)Exmoor Plastics , Ltd.2010-05-10
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L (K100274)Medtronic, Inc.2010-05-10
HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED (K100006)Riverpoint Medical2010-05-10
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 (K100289)Siemens Healthcare Diagnostics2010-05-10
CENTRAL VISION ANALYZER MODEL 1000 (K100095)Vimetrics,Llc.2010-05-10
SALVIN DENTAL SPECIALTIES FIXATION SCREW (K100182)Salvin Dental Specialties, Inc.2010-05-10
OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE (K093813)Imbiotechnologies2010-05-10
ACTIPROTECT UF N95 RESPIRATOR (K093161)Glaxosmithkline Consumer Healthcare2010-05-10
VLOC9ABSORBABLE WOUND CLOSURE DEVICE (K100257)Surgical Devices, A Division of Tyco Healthcare2010-05-10
INTCO TAB ELECTRODE (K093327)Shanghai Intco Electrode Manufacturing Co., Ltd.2010-05-10
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS (K093747)C.R. Bard, Inc.2010-05-07
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 (K100619)Siemens Medical Solutions USA, Inc.2010-05-07
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 (K101067)Philips Medical Systems2010-05-07
FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS (K091812)Frontier Devices, Inc.2010-05-07
HYALO GYN (K094039)Fidia Farmaceutici S.P.A.2010-05-07
VITALOGIK 6000/6500 (K093766)Mennen Medical , Ltd.2010-05-07
MEDCOM RT-VIEWER SYSTEM (K100056)Medcom GmbH2010-05-07
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V (K091336)Enthermics Medical Systems, Inc.2010-05-07
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M (K092476)Sport-Elec2010-05-07
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM (K094002)Spartek Medical, Inc.2010-05-07
BLOOD PRESSURE MONITOR/ MODELS (K093739)Ningbo Diaier Electronic Co., Ltd.2010-05-07
PARI SINUS (K092560)Pari Respiratory Equipment, Inc.2010-05-06
MED CONTOUR (K091615)General Project S.R.L.2010-05-06
SPECTRUM TURBO-JECT PICC SET (K100974)Cook Incorporated2010-05-06
A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH (K092097)A.B. Korkor Medical, Inc.2010-05-06
CAREVENT HANDHELD CPAP SYSTEM (K093862)O-Two Medical Technologies, Inc.2010-05-06
STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 (K100852)Stryker Communications2010-05-06
BUSSE SURGICAL DRAPES IV (K093909)Busse Hospital Disposables, Inc.2010-05-06
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED (K092467)Brainlab AG2010-05-06
AEQUALIS REVERSED SHOULDER PROSTHESIS (K100142)Tornier2010-05-06
SLENDERTONE SYSTEM ULTRA MODEL E70/X70 (K100320)Bio-Medical Research, Ltd.2010-05-05
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A (K100778)Siemens Healthcare Diagnostics2010-05-05
BIOLOX DELTA CERAMIC FEMORAL HEADS (K100412)Smith & Nephew, Inc.2010-05-05
SURGIQUEST ANCHORPORT SIL KIT (K100180)Surgiquest, Inc.2010-05-05
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR (K092302)Bettercare Plastic Products Co., Ltd.2010-05-05
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K100486)Zibo Yinghao Medical Products Co., Ltd.2010-05-05
PARIE TENE PROGRIP MESH (K101197)Sofradim Production2010-05-05
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM (K100830)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-05-05
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT (K100187)Medica Corp.2010-05-05
FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM (K094005)Taidoc Technology Corporation2010-05-05
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B (K100508)Carematix, Inc.2010-05-05
PASCAL STREAMLINE PHOTOCOAGULATOR (K100019)Optimedica Corporation2010-05-04
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 (K100423)ETHICON, Inc.2010-05-04
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Every clearance here is in the API, with alerts when new ones post.