Atlas FDA

2010

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

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RecordFirmDate
2008 HEMODIALYSIS SORBENT SYSTEM (K093362)Renal Solutions, Inc.2010-08-13
INQUIRY AFOCUSII DIAGNOSTIC CATHETER (K101623)St Jude Medical2010-08-13
PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE (K100098)Jm System Co., Ltd.2010-08-13
GAUNYING INFRARED LAMP (K102149)Foshan Gaunying Electronics Co., Ltd.2010-08-13
POSTURETEK (K093553)Perseus Althetics,Llc2010-08-13
PILOT DIODE LASER, MODEL 002-00139 (K100143)CAO Group, Inc.2010-08-13
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 (K093459)Phadia US, Inc.2010-08-13
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS (K102037)Apex BioTechnology Corp.2010-08-13
SPAPLUS (K100179)The Binding Site Group , Ltd.2010-08-13
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX (K100786)Bsd Medical Corp.2010-08-13
FASTPACK TSH IMMUNOASSAY (K101390)Qualigen, Inc.2010-08-13
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (K092991)Environmental Tectonics Corp.2010-08-13
AESCULAP PEEK CRANIOFIX (K091692)Aesculap, Inc.2010-08-12
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE (K100978)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-12
AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX (K101051)Stryker Spine2010-08-12
GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND (K102113)Ge Medical Systems China Co., Ltd.2010-08-12
KYPH X HV-R BONE CEMENT (K093828)Medtronic, Inc.2010-08-12
NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' (K101967)Ellman Int'L, Inc.2010-08-12
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT (K100389)Handpiece Headquarters2010-08-12
STAINLESS STEEL SPINAL SYSTEM (K100970)Theken Spine, LLC2010-08-12
ORLOCATE SYSTEM MODEL ORL 100 (K100551)Haldor Advanced Technologies, Ltd.2010-08-12
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K101757)Sonosite,Inc.2010-08-12
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE (K100977)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-12
VITABLOCS (K102128)Vita Zahnfabrik H.Rauter GmbH & Co.2010-08-11
HYBRID TROCAR SYSTEM (K101937)Aesculap, Inc.2010-08-11
WATERLASE MD TURBO PLUS MODEL 7200XXX (K101658)Biolase Technology, Inc.2010-08-11
COMBAT READY CLAMP (K102025)Combat Medical Systems, LLC2010-08-11
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 (K101660)Kepler Medtec2010-08-11
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX (K100865)Stryker Spine2010-08-11
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES (K093692)Pioneer Surgical Technology2010-08-11
HOSPIRA INFUSION BLOOD SETS (K101677)Hospira, Inc.2010-08-11
OMNI III PATIENT MONITOR (K101052)Infinium Medical2010-08-11
ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 (K091310)Dfine, Inc.2010-08-11
WINGMAN EXTENDABLE TIP SUPPORT CATHETER (K101479)Reflow Medical2010-08-11
COLLAGEN DENTAL MEMBRANE V (K100156)Collagen Matrix, Inc.2010-08-11
PROTEKTOR 32 (K093304)Natus Medical, Inc.2010-08-11
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR (K101751)Varian Medical Systems, Oncology Systems2010-08-10
SYNGO. PLAZA VA20A (K101666)Siemens AG Medical Solutions2010-08-10
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER (K101960)Edan Instruments, Inc.2010-08-10
LIFELINES PHOTIC STIMULATOR (K101691)Lifelines , Ltd.2010-08-10
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 (K101372)Baylis Medical Co., Inc.2010-08-10
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM (K093771)Pioneer Surgical Technology2010-08-10
ARP POV SPORT (K093999)Arp Manufacturing, Inc.2010-08-10
ATLAS SPINE PIVOTING SYSTEM (K100743)Atlas Spine, Inc.2010-08-10
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING (K100693)Medtrade Products Limited2010-08-10
EVOLUTION UNICONDYLAR KNEE SYSTEM (K100973)Wrightmedicaltechnologyinc2010-08-10
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 (K091090)E-Woo Technology2010-08-09
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW (K101452)Capintec, Inc.2010-08-09
VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY (K100887)Tag Medical Products2010-08-09
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 (K101134)Medicel AG2010-08-09
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS (K101122)Benz Research and Development Corp.2010-08-09
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 (K100918)Puricore, Inc.2010-08-09
ALLURA XPER OR TABLE SERIES (K102005)Philips Medical Systems North America, Inc.2010-08-09
WELLMIEN SURGICAL MASK (K101000)Wellmien (Suzhou) Import & Export Trading Co., Ltd.2010-08-09
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R (K101212)Medtronic, Inc.2010-08-07
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 (K100376)Earlysense, Ltd.2010-08-06
HEADWAY 17 ADVANCED MICROCATHETER (K101542)MicroVention, Inc.2010-08-06
MISSION SALIVA ALCOHOL TEST STRIP (K093879)ACON Laboratories, Inc.2010-08-06
STINGRAY ORIENTING BALLOON CATHETER (K101591)Bridgepoint Medical2010-08-06
SEILER COLPOSCOPE, MODELS 935, 955 AND 985 (K101141)Seiler Precision Microscopes2010-08-06
BUSSE EPIDURAL CATHETER KIT (K093920)Busse Hospital Disposables2010-08-06
VASOPRESS SUPREME MINI MODEL VP500DM (K101915)Compression Therapy Concepts, Inc.2010-08-06
ENDOSCOPIC CLIP SYSTEM (K102081)Aesculap, Inc.2010-08-06
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (K092029)Draeger Medical AG & Co. KG2010-08-06
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE (K101595)Better Care Plastic Technology Cp., Ltd.2010-08-06
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S (K102022)Avinger, Inc.2010-08-06
ABL90 FLEX SERIES (K092686)Radiometer Medical Aps2010-08-06
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 (K101647)Avinger, Inc.2010-08-06
OCCLUSION BALLOON CATHETER MODEL OBC (K101877)Cook, Inc.2010-08-06
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K101508)Ion Beam Applications S.A.2010-08-06
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100963)Hebei Shenzichen Plastic & Rubber Products Co., LT2010-08-06
LANX SPINAL FIXATION SYSTEM (K100935)Lanx, Inc.2010-08-06
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY (K102001)Smith & Nephew, Inc.2010-08-06
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM (K102065)Medison Co., Ltd.2010-08-06
ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I (K094021)Microsulis Medical Limited2010-08-06
TISSU TRANS FILTRON SYRINGE FILL (K102117)Shippert Medical Technologies Corp.2010-08-06
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS (K101298)Endochoice, Inc.2010-08-05
I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM (K093868)I.T.S. Implantat-Technologie-Systeme GmbH2010-08-05
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 (K100382)Salumedica, LLC2010-08-05
WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM (K100820)Wenzel Spine2010-08-05
MULTI-PURPOSE HEALTH DEVICE (K093322)Upc Medical Supplies, Inc. Dba United Pacific Co.2010-08-05
MODIFICATION TO SYNTHES MATRIX SYSTEM (K100952)Synthes Spine2010-08-05
ICAD VERALOOK CTC CAD SOFTWARE (K091529)Icad, Inc.2010-08-04
CONTRALCO (K100879)Contralco2010-08-04
CORRIDOR4DM V2010 MODEL: V2010 (K101279)Invia2010-08-04
SCANDIA-45 GAMMA CAMERA SYSTEM (K101391)Scandia Corporation2010-08-04
CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K (K101198)Computerized Screening, Inc.2010-08-04
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE (K101747)Kaz USA, Inc (A Subsidiaryof Kaz Inc)2010-08-04
REEFLEX PTA CATHETER (K101361)ClearStream Technologies , Ltd.2010-08-04
DUSIMETRY CHECK (K101503)Math Resolutions, LLC2010-08-04
NEOTRACT ANCHOR SYSTEM MODEL TAS400 (K102028)Neotract, Inc.2010-08-04
ORTHOMAP 3D 1.1 MODULE (K093206)Stryker Corp.2010-08-04
ALIGN RADIAL HEAD SYSTEM (K092721)Skeletal Dynamics, LLC2010-08-03
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES (K100966)Sheathing Technologies, Inc.2010-08-03
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB (K101289)Air Techniques, Inc.2010-08-03
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, (K101180)Smiths Medical MD, Inc.2010-08-03
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM (K100776)Synthes (Usa)2010-08-03
NEOMED ENTERAL ONLY EXTENSION SET (K100288)Neomed, Inc.2010-08-03
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 (K092892)I-Ming Sanitary Materials Co., Ltd.2010-08-03
DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN (K101387)Fudakang Industries Co., Ltd.2010-08-03
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Every clearance here is in the API, with alerts when new ones post.