FDA 510(k) clearances — page 377

176,542 clearances on record, most recent first.

Clearances — page 377

37,601–37,700 of 176,542

K140369 — MEDLINE NEURO SPONGEMedline Industries, Inc.·Product code HBA·2014-09-26
K140380 — OPERA SWINGGeneral Medical Merate S.P.A·Product code JAA·2014-09-26
K141075 — SINGLE-SITE WRISTED NEEDLE DRIVERIntuitive Surgical·Product code NAY·2014-09-26
K141097 — CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USETouchstone International Medical Science Co., Ltd.·Product code GDW·2014-09-26
K141113 — SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVESpacelabs Healthcare, Ltd.·Product code DXN·2014-09-26
K141271 — AERODR SYSTEM 2Konica Minolta, Inc.·Product code MQB·2014-09-26
K141380 — PROVOX FREEHANDS FLEXIVOICEAtos Medical AB·Product code EWL·2014-09-26
K141490 — UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SETVarian Medical Systems, Inc.·Product code JAQ·2014-09-26
K141800 — PERFRACTIONSun Nuclear Corporation·Product code IYE·2014-09-26
K141905 — PRO-LINK WEDGE SYSTEMLife Spine·Product code HRS·2014-09-26
K141935 — STRYKER S2 DRILLStryker Corporation·Product code ERL·2014-09-26
K142085 — DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5TGe Medical Systems, LLC·Product code LNH·2014-09-26
K142339 — HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC·Product code MTJ·2014-09-26
K142418 — I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH·Product code HRS·2014-09-26
K133603 — PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATIONPhilips Medical Systems·Product code JAK·2014-09-25
K140088 — PHANTOM XL INSULATED DILATORSTedan Surgical Innovations, LLC·Product code PDQ·2014-09-25
K140378 — FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUITOmniguide, Inc.·Product code GEX·2014-09-25
K140670 — ELLIPSE I2PL+/ELLIPSE MULTIFLEX+Ellipse A/S·Product code ONF·2014-09-25
K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTUREDemetech Corp.·Product code GAQ·2014-09-25
K141150 — PTA BALLOON DILATATION CATHETERBoston Scientific Corp·Product code LIT·2014-09-25
K141358 — CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBESMauna Kea Technologies·Product code OWN·2014-09-25
K141804 — POLARIS SPINAL SYSTEM - HA COATEDBiomet Spine, LLC·Product code NKB·2014-09-25
K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMSynthes USA Products, LLC·Product code KWP·2014-09-25
K142000 — ESOFLIP ESCrospon, Ltd.·Product code PIE·2014-09-25
K142383 — Optima XR200amx, Optima XR220amxGe Medical Systems, LLC·Product code IZL·2014-09-25
K142408 — FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)Polymed Therapeutics, Inc.·Product code LDJ·2014-09-25
K142546 — TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc.·Product code DRE·2014-09-25
K132121 — STATSTRIP GLUCOSE HOSPITAL METER SYSTEMNova Biomedical Corporation·Product code PZI·2014-09-24
K133456 — POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETERC.R. Bard, Inc.·Product code NIE·2014-09-24
K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEMApplied Medical Technology, Inc.·Product code CBH·2014-09-24
K140556 — CONCHASMART BREATHING CIRCUITTeleflex, Inc.·Product code BTT·2014-09-24
K140837 — LUCID LYBio-Med USA, Inc.·Product code GEX·2014-09-24
K141591 — SMARTGRAFT 30 SYSTEMIngeneron, Inc.·Product code MUU·2014-09-24
K141829 — GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEMCeragem Medisys, Inc.·Product code NBW·2014-09-24
K142123 — REACH ACCESS TELEMEDICINE DOSE CALCULATORReach Health, Inc.·Product code NDC·2014-09-24
K142261 — Ultraverse 035 PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.·Product code LIT·2014-09-24
K142376 — Palomar Icon Aesthetic SystemCynosure, Inc.·Product code GEX·2014-09-24
K141103 — INTRAMEDULLARY NAIL AND SCREWS-NEONAILNeoortho Produtos Ortopedicos S/A·Product code HSB·2014-09-23
K141483 — BIOSPACE BODY COMPOSITION ANALYZERBiospace Corporation Limited·Product code MNW·2014-09-23
K141500 — OPTIO-C ANTERIOR CERVICAL SYSTEMZimmer Spine, Inc.·Product code KWQ·2014-09-23
K141616 — STERILIZATION CASSETTEOticon Medical AB·Product code KCT·2014-09-23
K142112 — 4WEB SPINAL IMPLANT PRODUCTS4Web, Inc.·Product code MAX·2014-09-23
DEN140019 — T2CANDIDA AND T2DX INSTRUMENTT2biosystems, Inc.·Product code PII·2014-09-22
K140077 — ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTEDAlbaad , Ltd.·Product code HEB·2014-09-22
K140349 — STARBRIGHT 5% SODIUM FLUORIDE VARNISHNanova Biomaterials, Inc.·Product code LBH·2014-09-22
K140719 — PICOSURE WORKSTATIONCynosure, Inc.·Product code GEX·2014-09-22
K141255 — SIMEX SUBGLOTTIC ASPIRATION SYSTEMSimex Medizintechnik GmbH·Product code BTA·2014-09-22
K133050 — ONE PLUS IMPLANT SYSTEMOsseofuse, Inc.·Product code DZE·2014-09-19
K133223 — XENMATRIX AB SURGICAL GRAFTC.R. Bard, Inc.·Product code PIJ·2014-09-19
K133298 — ENDO SMARTMeta Biomed, Inc.·Product code EKX·2014-09-19
K133717 — LONGBOW SPACER SYSTEMLife Spine·Product code MAX·2014-09-19
K133753 — MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTORInfobionic, Inc.·Product code QYX·2014-09-19
K133852 — APOLLO BALLOON DILATATION CATHETERBrosmed Medical·Product code LOX·2014-09-19
K140634 — extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing KitDevon Medical, Inc.·Product code OMP·2014-09-19
K141437 — XLR8 PLUS (XLR8+)Genadyne Biotechnologies, Inc.·Product code OMP·2014-09-19
K141453 — ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETERLightlab Imaging, Inc.·Product code DQO·2014-09-19
K141472 — VANTAGE ELANToshiba America Medical Systems, In.C·Product code LNH·2014-09-19
K141669 — SURGIMAPNemaris, Inc.·Product code LLZ·2014-09-19
K141806 — CLEAR GUIDE ONEClear Guide Medical·Product code IYO·2014-09-19
K141998 — SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERSPinghu Sama Medical Packing Co., Ltd.·Product code DXQ·2014-09-19
K142397 — Predicate III GuidewireLake Region Medical·Product code OCY·2014-09-19
K142527 — Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.·Product code FPA·2014-09-19
K130312 — IROOT FMInnovative Bioceramix, Inc.·Product code KIF·2014-09-18
K131173 — FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc.·Product code NBW·2014-09-18
K140399 — EBM IDO VIEWEREbm Technologies USA, LLC·Product code LLZ·2014-09-18
K140557 — MIVI 6F GUIDE CATHETERMivi, LLC·Product code DQY·2014-09-18
K140613 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEMEllipse Technologies, Inc.·Product code PGN·2014-09-18
K141074 — CORTEX ID SUITEGe Medical Systems, LLC·Product code KPS·2014-09-18
K141477 — DISCOVERY IQGe Medical Systems, LLC·Product code KPS·2014-09-18
K141607 — DENTAL IMAGING SOFTWARETrophy·Product code LLZ·2014-09-18
K141670 — ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIAJohnson & Johnson Vision Care, Inc.·Product code LPL·2014-09-18
K141696 — EDWARDS ESHEATH INTRODUCER SETEdwards Lifesciences·Product code DYB·2014-09-18
K141697 — XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEMZimmer, Inc.·Product code KTT·2014-09-18
K141885 — CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAYMinxray, Inc.·Product code IZL·2014-09-18
K141895 — MOBILEDIAGNOST WDRSedecal., Sa.·Product code IZL·2014-09-18
K141985 — TRUE BA V BALLOON VALVULOPLASTY CATHETERC.R. Bard, Inc.·Product code OZT·2014-09-18
K142181 — RANDOX ALDOLASE CALIBRATION SERUMRandox Laboratories Limited·Product code JIT·2014-09-18
K142325 — Veenstra Instruments VDC-506 Dose CalibratorComecer Netherlands B.V.·Product code KPT·2014-09-18
K123329 — DA VINVI SURGICAL SYSTEMIntuitive Surgical, Inc.·Product code NAY·2014-09-17
K134035 — TRANSONIC HCM 103 SYSTEMTransonic Systems, Inc.·Product code DXG·2014-09-17
K140416 — TREKKER, TREKKER TRANSITConvaid Products, Inc.·Product code IOR·2014-09-17
K141069 — Lung Density AnalysisImbio, LLC·Product code JAK·2014-09-17
K141260 — ELECTRONIC PULSE STIMULATORShenzhen Jingkehui Electronic Co.., Ltd.·Product code NUH·2014-09-17
K141450 — AXIOM 2.8Anthogyr Sas·Product code DZE·2014-09-17
K141481 — TRC-NW400 NON-MYDRIATIC RETINAL CAMERATopcon Corporation·Product code HKI·2014-09-17
K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPEPropper Manufacturing Co., Inc.·Product code HLI·2014-09-17
K142048 — EMPRINT PROCEDURE PLANNING APPLICATIONCovidien, LLC·Product code LLZ·2014-09-17
K142179 — D-KAT Z-YPEKeeler, Ltd.·Product code HKY·2014-09-17
K142300 — Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc.,·Product code LIT·2014-09-17
K142336 — GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring SystemArkray Factory, Inc.·Product code CGA·2014-09-17
K140017 — TRANSONIC HCM 102 SYSTEMTransonic Systems, Inc.·Product code DXG·2014-09-16
K140377 — XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)Luminex Molecular Diagnostics, Inc.·Product code PCH·2014-09-16
K140496 — Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System ReagentsBeckman Coulter, Inc.·Product code CDD·2014-09-16
K141108 — YUSHENGZibo Yusheng Plastic Products Co., Ltd.·Product code LYZ·2014-09-16
K141405 — MOBIS II ST SPINAL IMPLANTSignus Medizintechnik GmbH·Product code MAX·2014-09-16
K142309 — GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc.·Product code MVR·2014-09-16
K140039 — POLYCRYLAurolab·Product code GAM·2014-09-15
K140362 — KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBESKatalyst Surgical, LLC·Product code HQF·2014-09-15
K140758 — M-PM-DISC (PINK)Merz Dental GmbH·Product code EBI·2014-09-15
K140912 — SOMATOM SCOPE/SOMATOM SCOPE POWERSiemens Medical Solutions USA, Inc.·Product code JAK·2014-09-15

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