Atlas FDA

2010

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

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RecordFirmDate
TINA-QUANT ALBUMIN GEN 2 (K101203)Roche Diagnostics2010-09-10
E.S.O. (ELECTRO SENSOR OXI) (K102442)Ld Technology, LLC2010-09-10
TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET (K102430)Tyco Electronics Corporation2010-09-10
NUGARD NITILE GREY COLOR (K102230)Terang Nusa Sdn Bhd2010-09-10
STAXX XD SYSTEM (K101288)Spine Wave, Inc.2010-09-10
ELECSYS FERRITIN CALCHECK 5 (K102267)Roche Diagnostics2010-09-10
STERILE SALINE SOLUTION (K093367)Cachet Pharmaceuticals Pvt. , Ltd.2010-09-10
ENDEAVOUR MONITORING SYSTEM (K102004)Mindray DS USA, Inc.2010-09-10
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM (K101696)Zimmer, Inc.2010-09-10
ACTA VESSEL OCCLUSION SYSTEM (VOS) (K091952)Nfocus Neuromedical, Inc.2010-09-10
SURGICAL FACE MASK (K093901)Epard Protective Products, Ltd.2010-09-10
KIRSCHNER AND GUIDE WIRES (K100736)Smt Schilling Metalltechnik GmbH2010-09-10
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (K101425)Siemens Healthcare Diagnostics2010-09-10
COBAS 8000 MODULAR SERIES ANALYZER (K100853)Roche Diagnostics Corp.2010-09-09
MEDTRONIC C315 DELIVERY CATHETER (K101885)Medtronic, Inc.2010-09-09
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK (K100985)BioHorizons Implant Systems, Inc.2010-09-09
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M (K101551)Delma Medical Instrument (Guangzhou) Co., Ltd.2010-09-09
EMS MINIMASTER LED (K093723)E.M.S Electro Medical Systems S.A2010-09-08
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS (K102032)Kimberly-Clark Corp.2010-09-08
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM (K101456)Roche Diagnostics2010-09-08
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR (K101646)Sgmp Co., Ltd.2010-09-08
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US (K101490)Thermage, Inc.2010-09-08
VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES (K101734)Visionscope Technologies, LLC2010-09-08
NEWPORT E360 VENTILATOR (K101803)Newport Medical Instruments, Inc.2010-09-08
SNORE GUARD ADVANCE (K102118)Ranir, LLC2010-09-08
HANDHELD PULSE OXIMETER MODEL M800 (K101694)Guangdong Biolight Meditech Co., Ltd.2010-09-08
STERIGAGE MODEL 1243RA, 1243RB, 1243RE (K101249)3M Company2010-09-08
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL (K101617)Heraeus Kulzer, LLC2010-09-07
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V (K101868)Toshiba America Medical Systems, In.C2010-09-07
NON-ABLATIVE WRINKLE TREATMENT HANDPIECE (K102368)Ellman Int'L, Inc.2010-09-07
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE (K101630)Pt. Smartglove Indonesia2010-09-07
6F ENGAGE/ENGAGE TR INTRODUCER (K101883)St Jude Medical2010-09-07
FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM (K100442)Surgical Innovations Group Plc2010-09-07
MERIT BIPOLAR COAGULATION PROBE (K102273)Merit Medical Systems, Inc.2010-09-07
SPAPLUS ANALYZER (K100455)The Binding Site2010-09-03
BIOGRAPH MCT FAMILY (K101550)Siemens Medical Solutions USA, Inc.2010-09-03
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG (K101186)Medtronic Perfusion Systems2010-09-03
OSSTAPLE CHILL (K102107)Biomedical Ent., Inc.2010-09-03
3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM (K101834)3M Company2010-09-03
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL (K101593)Exact Medical Manufacturing, Inc.2010-09-03
TAPERLOC COMPLETE (K101086)Biomet, Inc.2010-09-03
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE (K100418)Covidien2010-09-03
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE (K101799)Wear Safe (Malaysia) Sdn. Bhd.2010-09-03
CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 (K091125)Verilux2010-09-03
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 (K100718)Aalto Scientific, Ltd.2010-09-03
CRUISER 18 GUIDEWIRE (K102211)Brivant, Ltd.2010-09-03
ECLIPSE TREATMENT PLANNING SYSTEM (K102011)Varian Medical Systems, Inc.2010-09-03
ROMIAPEX MODEL A-15 (K101054)Romidan, Ltd.2010-09-03
SHARPS CONTAINER (K101567)Cixi Leinuo Plastic Co., Ltd.2010-09-02
NMI IC (K101326)Navilyst Medical, Inc.2010-09-02
EASY TOUCH (K102178)Mhc Medical Products2010-09-02
VU APOD INTERVERTEBRAL BODY FUSION DEVICE (K101310)Theken Spine, LLC2010-09-02
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) (K091969)Euroimmun Us, Inc.2010-09-02
QUINTEX CERVICAL PLATING SYSTEM (K100243)Aesculap Implant Systems, LLC2010-09-02
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING (K100795)Smith & Nephew, Inc.2010-09-02
EUROIMMUN ANTI-M2-3E ELISA (IGG) (K092736)Euroimmun Us, Inc.2010-09-02
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK (K101130)Respironics, Inc.2010-09-02
NIOX MINO MODEL 09-1000 (K101034)Aerocrine AB2010-09-02
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. (K093430)Exactech, Inc.2010-09-02
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT (K101860)Novabone Products, LLC2010-09-01
NESSI OTC SPACER (K101532)Pharmacaribe2010-09-01
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM (K102020)Spinefrontier, Inc.2010-09-01
VITAL SIGNS MONITOR (K101602)Criticare Systems, Inc.2010-09-01
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 (K102176)Medtronic Cryocath, LP2010-09-01
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES (K101506)Palomar Medical Technologies, Inc.2010-09-01
PRECICONTROL CLINCHEM MULTI 1 AND 2 (K102016)Roche Diagnostics2010-09-01
EXPEDIUM SPINE SYSTEM (K101070)Medos International SARL2010-08-31
ELECSYS DIGOXIN CALCHECK 5 (K102044)Roche Diagnostics2010-08-31
GE LOGIQ P5 MODEL H44662LD (K101878)GE Healthcare2010-08-31
CS-SERIES-FP (K100102)Omega Medical Imaging, Inc.2010-08-31
AUDIT MICROCV RF/CRP LINEARITY SET (K101226)Aalto Scientific, Ltd.2010-08-31
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (K100518)Instrumed International, Inc.2010-08-31
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS (K101714)Nobel Biocare AB2010-08-31
MR RADIATION ONCOLOGY OPTIONS (K102155)Ge Medical Systems, LLC2010-08-31
ARCHER SUPER STIFF GUIDEWIRES (K101339)Medtronic, Inc.2010-08-31
FASTX STERNAL INTRAOSSEOUS DEVICE (K100124)Pyng Medical Corp.2010-08-31
TENS STIMULATOR, MODELS 2800 AND 3000 (K102014)Koalaty Products, Inc.2010-08-31
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL (K101600)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010-08-31
FREQUENCER MODEL V2X (K100749)Dymedso, Inc.2010-08-31
MYLABONE ULTRASOUND SYSTEM (K101605)Esaote Europe B.V.2010-08-31
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 (K101950)Andon Health Co, Ltd.2010-08-31
IQ 200 URINE ANALIZER BODY FLUIDS MODULE (K091539)Iris Diagnostics2010-08-31
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS (K093689)Mr Medical Solutions, LLC2010-08-31
GELSCAN, MODEL 1206 (K100307)Sebia2010-08-31
3DHJD CAMERA SYSTEM MODEL (K101810)Vision Systems Group, A Division of Viking Systems2010-08-30
CYBERWAND LITHOTRIPTER (K102169)Cybersonics, Inc.2010-08-30
CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C (K093725)Canada Endoscope Corporation2010-08-30
1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 (K100998)Unilife Medical Solutions Limited2010-08-30
ASCENSION MODULAR TOTAL SHOULDER SYSTEM (K100448)Ascension Orthopedics, Inc.2010-08-30
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 (K092449)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-08-30
TEPHAFLEX COMPOSITE MESH (K101287)Tepha, Inc.2010-08-30
BLOOD PRESSURE METER, MODEL CH-609 (K100055)Citizen Systems Japan Co., Ltd.2010-08-30
ST AIA PACK HBA1C (K100304)Tosoh Bioscience, Inc.2010-08-27
MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS (K101702)Midwest Reprocessing Center, LLC2010-08-27
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, (K101199)Maquet Critical Care AB2010-08-27
TX1 TISSUE REMOVAL SYSTEM (K101561)American Optisurgical, Inc.2010-08-27
ELECSYS PRECICONTROL MULTIMARKER (K102157)Roche Diagnostics2010-08-27
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 (K100635)Arrow Intl., Inc.2010-08-27
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (K101832)Medical Device Technologies, Inc.2010-08-27
ENDOTRACHEAL TUBE CHANGERS (K102127)Instrumentation Industries, Inc.2010-08-27
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Every clearance here is in the API, with alerts when new ones post.