FDA 510(k) clearances — page 316

176,542 clearances on record, most recent first.

Clearances — page 316

31,501–31,600 of 176,542

K161241 — e-fix E35/E36Alber GmbH·Product code ITI·2016-10-05
K161480 — R2 Dermal Cooling SystemR2 Dermatology·Product code GEH·2016-10-05
K161560 — Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.·Product code DQA·2016-10-05
K161885 — The Cellfina SystemUlthera, Inc.·Product code OUP·2016-10-05
K161925 — CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.·Product code GEX·2016-10-05
K160731 — LumFix Spinal Fixation SytemCG Bio Co., Ltd.·Product code MNI·2016-10-04
K160909 — ATTO Mobility ScooterMoving Life, Ltd.·Product code INI·2016-10-04
K161050 — ACTABOND Topical Skin AdhesiveBergen Medical Products, Inc.·Product code MPN·2016-10-04
K161075 — Arrow Epidural Catheter KitTeleflexmedical, Inc.·Product code CAZ·2016-10-04
K161727 — Eyenez Ophthalmic CameraEyenez, LLC·Product code HKI·2016-10-04
K161854 — Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUSThe Binding Site Group , Ltd.·Product code PCN·2016-10-04
K161897 — PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.)·Product code OMP·2016-10-04
K162494 — CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.·Product code NKB·2016-10-04
K152579 — FilmArray Respiratory Panel EZ (RP EZ)Biofire Diagnostics, LLC·Product code OCC·2016-10-03
K152970 — Dynarex Xeroform Petrolatum DressingDynarex Corporation·Product code FRO·2016-10-03
K153539 — RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.·Product code IYN·2016-10-03
K153760 — Volumetric Infusion ControllerDEKA Research & Development·Product code LDR·2016-10-03
K160060 — DMi Dental Implant SystemDmi Innovative Medical Technology , Ltd.·Product code DZE·2016-10-03
K161458 — Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc.·Product code PBX·2016-10-03
K161828 — kneeEOSOnefit Medical·Product code LLZ·2016-10-03
K161881 — PreXion3D ExcelsiorPrexion Corporation·Product code OAS·2016-10-03
K162269 — Voluson E6, Voluson E8, Voluson E10GE Healthcare·Product code IYN·2016-10-03
K162504 — SKR 3000Konica Minolta, Inc.·Product code MQB·2016-10-03
K162549 — Lumify Ultrasound SystemPhilips Health Care·Product code IYN·2016-10-03
K161576 — Esophagus Bougie SetVarian Medical Systems, Inc.·Product code JAQ·2016-10-02
K162276 — SeraQuest Herpes Type 1 Specific IgGQuest International, Inc.·Product code MXJ·2016-10-01
K151964 — Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics·Product code GJS·2016-09-30
K153156 — eCareManager 4.0.1Visicu, Inc.·Product code MSX·2016-09-30
K160023 — Electronic Stethoscope DS301Imediplus, Inc.·Product code DQD·2016-09-30
K160140 — DENTRIa seriesHdx Will Corp.·Product code OAS·2016-09-30
K160443 — TempoCem ClearDmg USA, Inc.·Product code EMA·2016-09-30
K161212 — Atteris Antimicrobial Skin ProtectantRochal Industries, LLC·Product code FRO·2016-09-30
K161232 — ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health·Product code BSO·2016-09-30
K161464 — Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC·Product code NLH·2016-09-30
K161608 — InterForm Cervical Interbody Cage SystemNext Orthosurgical·Product code ODP·2016-09-30
K161774 — i-SilSpident Co., Ltd.·Product code ELW·2016-09-30
K161803 — Traxcess .007 Mini GuidewireMicroVention, Inc.·Product code MOF·2016-09-30
K161875 — LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc.·Product code OAP·2016-09-30
K162187 — Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation·Product code IYN·2016-09-30
K162527 — 8MP Color LCD Monitor (C81W+)Shenzhen Beacon Display Technology Co., Ltd.·Product code PGY·2016-09-30
K152163 — RENASYS GOSmith & Nephew, Inc.·Product code OMP·2016-09-29
K160410 — WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small headDental Savings Club·Product code EFB·2016-09-29
K160436 — CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.·Product code NHA·2016-09-29
K161379 — ELSA SpacersGlobus Medical, Inc.·Product code OVD·2016-09-29
K161424 — Phasix MeshC.R. Bard, Inc.·Product code OOD·2016-09-29
K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB·Product code LXB·2016-09-29
K161672 — SpeediCath Flex CoudeColoplast Corp.·Product code GBM·2016-09-29
K162059 — EZEE RETRIEVALGenicon, Inc.·Product code GCJ·2016-09-29
K162126 — Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)ArthroCare Corporation·Product code GEI·2016-09-29
K162332 — Nexcore GI InsufflatorNexcore Technology, LLC·Product code FCX·2016-09-29
K162416 — IRIDEX Cyclo G6 Laser System, G-Probe IlluminateIridex Corporation·Product code GEX·2016-09-29
K162426 — nva, nvp, and nvtNvision Biomedical Technologies, LLC·Product code MAX·2016-09-29
K153546 — PINK CAD/CAM discPolident D.O.O., Dental Products Industry·Product code EBI·2016-09-28
K160136 — Flowable Wound MatrixCook Biotech Incorporated·Product code KGN·2016-09-28
K160365 — BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.·Product code NBW·2016-09-28
K161002 — Aprima Smartesis Centesis PumpCook Incorporated·Product code BTA·2016-09-28
K161014 — NuVasive® Reline® SystemNu Vasive, Incorporated·Product code NKB·2016-09-28
K161173 — Avenue® T TLIF CageLdr Spine USA, Inc.·Product code OVD·2016-09-28
K161442 — NuVasive® CoRoent® Small Interlock SystemNu Vasive, Incorporated·Product code OVE·2016-09-28
K161562 — Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc.·Product code KLW·2016-09-28
K162417 — Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.·Product code IYN·2016-09-28
K152865 — TRACOE smart Cuff ManagerTracoe Medical GmbH·Product code BSK·2016-09-27
K160630 — Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation·Product code CAW·2016-09-27
K160818 — STERRAD® NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products·Product code MLR·2016-09-27
K160825 — MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona·Product code EKX·2016-09-27
K160957 — CDB Self Ligating Bracket 8FCdb Corporation·Product code NJM·2016-09-27
K161446 — Biopor Porous Polyethylene ImplantsCeremed , Inc.·Product code GWO·2016-09-27
K161814 — Solana Influenza A+B AssayQuidel Corporation·Product code OCC·2016-09-27
K161984 — Interlocked Circular Small Field Collimators, Elekta IntegratedAktina Medical Corporation·Product code IYE·2016-09-27
K162107 — TPH Spectra+ Universal Composite RestorativeDentsply Sirona·Product code EBF·2016-09-27
K162307 — OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.·Product code HRS·2016-09-27
DEN150033 — Sensor Monitored Alimentary Restriction Therapy (SMART) DeviceScientific Intake·Product code ONY·2016-09-26
K160167 — DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC·Product code HSB·2016-09-26
K160903 — STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products·Product code MLR·2016-09-26
K160945 — Endophys Blood Pressure MonitorEndophys Holdings, LLC·Product code DSK·2016-09-26
K161185 — LUCERNA Dental LaserViax Dental Lab·Product code GEX·2016-09-26
K161506 — Penumbra Aspiration SystemPenumbra, Inc.·Product code QEW·2016-09-26
K161825 — PK AIMGyrus Acmi, Inc.·Product code GEI·2016-09-26
K161838 — Xenocor Xenoscope Laparoscopic SystemXenocor, Inc.·Product code GCJ·2016-09-26
K161878 — PORTAGE SystemBaylis Medical Company, Inc.·Product code HRX·2016-09-26
K151285 — VSP Cranial System3D Systems, Inc.·Product code PPT·2016-09-23
K160640 — PASS XS Spinal SystemMedicrea International SA·Product code NKB·2016-09-23
K160657 — BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company·Product code JKA·2016-09-23
K160880 — Photonica ProfessionalWard Photonics, LLC·Product code OLI·2016-09-23
K161832 — O2VENT TOventus Manufacturing Pty, Ltd.·Product code LRK·2016-09-23
K161945 — EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.·Product code JWH·2016-09-23
K162143 — FixxSure® X-LinkInnovasis, Inc.·Product code MNH·2016-09-23
K153565 — DONASORB SILVER WOUND DRESSINGVirchow Biotech Pvt, Ltd.·Product code FRO·2016-09-22
K153761 — Emergency Transtracheal Airway CatheterCook Incorporated·Product code BWC·2016-09-22
K160015 — Pure VuMotus GI Medical Technologies , Ltd.·Product code FDF·2016-09-22
K160860 — MiniMed Quick-serterMedtronic Minimed·Product code KZH·2016-09-22
K161068 — Ahead 300Brainscope Company, Inc.·Product code PIW·2016-09-22
K161368 — DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)Agfa Healthcare N.V.·Product code MQB·2016-09-22
K161451 — BIB Stent Placement CatheterNuMED, Inc.·Product code NVM·2016-09-22
K161992 — Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation·Product code JXG·2016-09-22
K161994 — Aerin Medical StylusAerin Medical, Inc.·Product code GEI·2016-09-22
K162188 — Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)Vr Medical Technology·Product code PNR·2016-09-22
K162224 — ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.·Product code KPR·2016-09-22
K162377 — PowerGlide Pro Midline CatheterC.R. Bard, Inc.·Product code FOZ·2016-09-22
K162384 — TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.)·Product code DQY·2016-09-22

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