FDA 510(k) clearances — page 370

176,542 clearances on record, most recent first.

Clearances — page 370

36,901–37,000 of 176,542

K140848 — LUMINESSE PORCELAIN SYSTEMTalladium, Inc.·Product code EIH·2014-12-17
K141163 — STERIZONE STERILIZERTso3, Inc.·Product code PJJ·2014-12-17
K141366 — VIDEO BRONCHOSCOPE SYSTEMScholly Fiberoptic GmbH·Product code EOQ·2014-12-17
K141580 — STERIZONE SELF-CONTAINED BIOLOGICAL INDICATORTso3, Inc.·Product code FRC·2014-12-17
K141691 — GEN_3Free Wheelchair Mission·Product code IOR·2014-12-17
K141698 — STERIZONE CHEMICAL INDICATORTso3, Inc.·Product code JOJ·2014-12-17
K142051 — PRELUDE PLASTIC JACKETED GUIDE WIREMerit Medical Systems, Inc.·Product code DQX·2014-12-17
K142089 — ACCU-CHEK AVIVA EXPERT SYSTEMRoche Diagnostics Corporation·Product code LFR·2014-12-17
K142164 — MANIPULATOR; MANIPULATOR PROGynetech Pty. , Ltd.·Product code LKF·2014-12-17
K142377 — The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC·Product code KNW·2014-12-17
K142492 — GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.·Product code IZL·2014-12-17
K142571 — Powder Free Vinyl Patient Examination GlovesEver Light Plastic Products Co., Ltd.·Product code LYZ·2014-12-17
K142718 — Radlink GPSRadlink, Inc.·Product code MQB·2014-12-17
K142721 — cobas MRSA/SA TestRoche Molecular Systems, Inc.·Product code NQX·2014-12-17
K142891 — HEPATIQHepatiq, LLC·Product code LLZ·2014-12-17
K142997 — RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc.·Product code LNH·2014-12-17
K143488 — InFill Graft Delivery SystemPinnacle Spine Group, LLC·Product code FMF·2014-12-17
K140860 — ImmersiveTouch3 and MicrovisTouchImmersivetouch·Product code LLZ·2014-12-16
K141009 — FORT DEFIANCE AUTOMATED STEAM STERILIZERFort Defiance Industries, Inc.·Product code FLE·2014-12-16
K141295 — MERIT HYDROPHILIC GUIDEWIREMerit Medical Systems, Inc.·Product code DQX·2014-12-16
K141775 — SOFIA (R) STREP A+ FIAQuidel Corporation·Product code GTY·2014-12-16
K142108 — RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSISBrainlab AG·Product code MUJ·2014-12-16
K142419 — Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A·Product code HRS·2014-12-16
K142639 — StitchKitOrigami Surgical, LLC·Product code GAW·2014-12-16
K142715 — Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC·Product code HJK·2014-12-16
K142772 — Phlebo Press DVT 603Mego Afek AC , Ltd.·Product code JOW·2014-12-16
K142789 — A1c iGear SystemSakae Corporation·Product code LCP·2014-12-16
K142919 — EXAViztek, LLC·Product code LLZ·2014-12-16
K142944 — ArthroPlan Digital Templating SoftwareArthromeda, Inc.·Product code LLZ·2014-12-16
K143052 — Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily +1 moreYung Sheng Optical Co., Ltd.·Product code LPL·2014-12-16
K143284 — Elecsys Estradiol III CalcheckRoche Diagnostics·Product code JJX·2014-12-16
K143296 — AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc.·Product code JJX·2014-12-16
DEN140010 — PERKINELMER ENLITE NEONATAL TREC TEST SYSTEMWallac OY·Product code PJI·2014-12-15
K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDECook, Inc.·Product code GCJ·2014-12-15
K140667 — WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETERWell Lead Medical Co., Ltd.·Product code EZL·2014-12-15
K140734 — NEXTGEN ALTIUS OCT SYSTEMEbi, LLC·Product code KWP·2014-12-15
K141330 — ENDO-CORDEnroxtech, Inc.·Product code FST·2014-12-15
K141513 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.·Product code KCT·2014-12-15
K141575 — PLAC TEST FOR LP-PLA2 ACTIVITYDiadexus, Inc.·Product code NOE·2014-12-15
K142329 — BBS REVOLUTIONDbmedx, Inc.·Product code IYO·2014-12-15
K142477 — Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation·Product code KNW·2014-12-15
K142490 — ProxiFuse Hammer Toe DeviceCartiva, Inc.·Product code HWC·2014-12-15
K142643 — Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc.·Product code MBI·2014-12-15
K143244 — The Panthera Anti-Snoring DevicePanthera Dental, Inc.·Product code LRK·2014-12-15
K143330 — BruxZir AnteriorPrismatik Dentalcraft, Inc.·Product code EIH·2014-12-15
K133795 — SUMMED INFLATION DEVICE KITSunny Medical Device (Shenzhen) Co., Ltd.·Product code MAV·2014-12-12
K140091 — XPEED ANYRIDGE INTERNAL IMPLANT SYSYEMMegagen Implant Co., Ltd.·Product code DZE·2014-12-12
K140202 — TRAUSIM DENTAL IMPLANT SYSTEMJiangsu Trausim Medical Instrument·Product code DZE·2014-12-12
K140350 — VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOLPreventive Technologies, Inc.·Product code LBH·2014-12-12
K140663 — THERASNOREDistar, LLC·Product code LRK·2014-12-12
K140680 — LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEMAlpine Biomed Aps·Product code GZL·2014-12-12
K140797 — IPACS MEDICAL IMAGE MANAGEMENT SYSTEMVisbion Limited·Product code LLZ·2014-12-12
K141303 — ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLORZhida Glove Co., Ltd.·Product code LZA·2014-12-12
K141304 — YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLORYongxin Healthcare Co., Ltd.·Product code LZA·2014-12-12
K141756 — INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATIONDraeger Medical Systems, Inc.·Product code MSX·2014-12-12
K142081 — CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGESOsprey Medical, Inc.·Product code DXT·2014-12-12
K142132 — POOL NORMDiagnostics Stago S.A.S.·Product code GGN·2014-12-12
K142180 — TELESENSEScottcare Corporation·Product code DSI·2014-12-12
K142384 — DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl·Product code LPL·2014-12-12
K142620 — 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL SyringeExcelsior Medical Corporation·Product code NGT·2014-12-12
K142975 — Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation·Product code GEI·2014-12-12
K140669 — G7 OSSEOTI ACETUBLAR SHELLSBiomet, Inc.·Product code LPH·2014-12-11
K141053 — OVINE TISSUE MATRIX(OTM)TELA Bio, Inc.·Product code FTM·2014-12-11
K141389 — SAPPHIRE INFUSION PUMPQ Core Medical , Ltd.·Product code FRN·2014-12-11
K142146 — IBIS PEDICLE SCREW SYSTEMOrtho Development Corp.·Product code NKB·2014-12-11
K142404 — iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.·Product code JWH·2014-12-11
K142560 — Varian Head FrameVarian Medical Systems, Inc.·Product code IYE·2014-12-11
K142607 — AngioVac CircuitAngiodynamics·Product code DWE·2014-12-11
K142661 — Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC·Product code FMF·2014-12-11
K142800 — Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.·Product code DKZ·2014-12-11
K133218 — Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc.·Product code OVE·2014-12-10
K140624 — HICURA HAND INSTRUMENTSOlympus Winter & Ibe GmbH·Product code GEI·2014-12-10
K141054 — DISTAL ACCESS TORQUE DEVICEDistal Access, LLC·Product code DQX·2014-12-10
K141213 — AMERIWATER OZONE DISINFECTION SYSTEMAmeriwater·Product code FIN·2014-12-10
K141463 — LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERSDiaSorin, Inc.·Product code MRG·2014-12-10
K141810 — BD BACTEC PLUS ANAEROBIC/F (PLASTIC)Becton, Dickinson and Company·Product code MDB·2014-12-10
K142343 — Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)Tangshan Hongyun Plastic Products Co., Ltd.·Product code LYZ·2014-12-10
K142683 — 12 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.·Product code NAY·2014-12-10
K142951 — MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions , Ltd.·Product code PGY·2014-12-10
K143125 — Orthofix True Lok Hexapod System VI.3Orthofix Srl·Product code KTT·2014-12-10
K143206 — AmpliVue Bordetella AssayQuidel Corporation·Product code OZZ·2014-12-10
K143254 — eSie Apps SuiteSiemens Medical Solutions USA, Inc.·Product code LLZ·2014-12-10
K140224 — EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)Euroimmun US·Product code LKO·2014-12-09
K141925 — TOTAL PROTEIN URINE/CSF GEN.3Roche Diagnostics Operations (Rdo)·Product code JIQ·2014-12-09
K142126 — EP NAVIGATOR REL. 5.0Philips Medical Systems Nederland B.V.·Product code OWB·2014-12-09
K142547 — Bluntport Blunt Trocar with Threaded Anchor 5mm-12mmCovidien·Product code GCJ·2014-12-09
K143208 — Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery KitC.R. Bard, Inc.·Product code DTK·2014-12-09
K143264 — H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.·Product code IYN·2014-12-09
K140665 — GenPrime Snap-Top Split Key CupGenprime, Inc.·Product code DIS·2014-12-08
K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.Randox Laboratories Limited·Product code JJY·2014-12-08
K141507 — TWO SKIN TREATMENT SYSTEMSyneron Medical, Ltd.·Product code GEI·2014-12-08
K141557 — HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBARGallini Medical Devices, Srl·Product code HRX·2014-12-08
K141760 — ORTHOFIX GALAXY WRISTOrthofix Srl·Product code KTT·2014-12-08
K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500R & D Batteries, Inc.·Product code MKJ·2014-12-08
K142264 — Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp.·Product code ODP·2014-12-08
K142433 — Hospira Extension SetHospira, Inc.·Product code FPA·2014-12-08
K132313 — PESSARYEis Corporation·Product code HHW·2014-12-05
K140705 — NAVIGABLE BRAIN BIOPSY CANNULA SETIzi Medical Products·Product code HAW·2014-12-05
K140838 — IV ADMINISTRATION SET WITH HAND PUMPB.Braun Medical, Inc.·Product code FPA·2014-12-05
K140847 — CARDIOSPY ECG HOLTER SYSTEMSLabtech Kft.·Product code MLO·2014-12-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.