FDA 510(k) clearances — page 336

176,542 clearances on record, most recent first.

Clearances — page 336

33,501–33,600 of 176,542

K160044 — Image1 SPIES SystemKarl Storz Endoscopy America, Inc.·Product code FET·2016-02-01
K143470 — Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme Laboratories·Product code GIS·2016-01-31
K153628 — ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC·Product code DRM·2016-01-30
K142664 — URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation·Product code LCP·2016-01-29
K150893 — IntelliCuffHamilton Medical AG·Product code BSK·2016-01-29
K151194 — KLOCKNER DENTAL IMPLANT ABUTMENTS (II)SOADCO, S.L.·Product code NHA·2016-01-29
K151426 — ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+Scandidos AB·Product code IYE·2016-01-29
K151735 — TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.·Product code HRS·2016-01-29
K151939 — COALITION SpacersGlobus Medical, Inc.·Product code OVE·2016-01-29
K152247 — ATLANTIS CrownDentsply International, Inc.·Product code EIH·2016-01-29
K152915 — EYE-SYNCSyncthink, Inc.·Product code GWN·2016-01-29
K153157 — Sonendo Gentle Wave SystemSonendo, Inc.·Product code ELC·2016-01-29
K153169 — PASS OCT Patient Specific RodsMedicrea International·Product code NKG·2016-01-29
K153428 — Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.·Product code NKB·2016-01-29
K153475 — SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc.·Product code KNG·2016-01-29
K151436 — PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.·Product code OMP·2016-01-28
K151716 — Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemZimmer, Inc.·Product code HRS·2016-01-28
K152188 — QUAD Dental Implants and ProsthesesDentack Impants, Ltd.·Product code DZE·2016-01-28
K152344 — Total BilirubinRandox Laboratories Limited·Product code JFM·2016-01-28
K152512 — Half Dome Posterior Lumbar Interbody SystemAstura Medical·Product code MAX·2016-01-28
K153129 — dynaMX Tabbed StapleMx Orthopedics, Corp.·Product code JDR·2016-01-28
K153186 — Adjustable Fixation DeviceArthrocare Corp.·Product code MBI·2016-01-28
K153423 — CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)·Product code LJS·2016-01-28
K153459 — TACVACAthena Gtx·Product code BTA·2016-01-28
K153525 — Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine·Product code NKB·2016-01-28
K153686 — SPIWay Endonasal Access GuideSpiway, LLC·Product code LYA·2016-01-28
K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.·Product code JJY·2016-01-28
K150672 — VistaCam iX ProofDurr Dental AG·Product code NBL·2016-01-27
K151354 — Cervello STIMBlackrock Neuromed·Product code GYC·2016-01-27
K151367 — Sydney IVF HyaluronidaseWilliam A. Cook Australia Pty. , Ltd.·Product code MQL·2016-01-27
K151787 — Holter SystemEdan Instruments, Inc.·Product code DQK·2016-01-27
K152233 — BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxSportarredo Group S.C.·Product code LEJ·2016-01-27
K152986 — StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation·Product code PZI·2016-01-27
K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst MediumWilliam A. Cook Australia Pty. , Ltd.·Product code MQL·2016-01-27
K153500 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.·Product code FZP·2016-01-27
K153729 — 8F FlowGate2 Balloon Guide CatheterConcentric Medical·Product code DQY·2016-01-27
K143615 — Antistatic Compact Space ChamberMedical Developments International Limited·Product code NVP·2016-01-26
K150498 — Discovery 24Brainmaster Technologies, Inc.·Product code GWQ·2016-01-26
K151259 — Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH·Product code JPA·2016-01-26
K151405 — Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings(Dba Medline Renewal·Product code NLQ·2016-01-26
K151701 — Tenodesis screw systemNormed Medizin-Technik GmbH·Product code HWC·2016-01-26
K151812 — PATIENT MONITORS VARIOUS MODELSPhilips Medical Systems·Product code MHX·2016-01-26
K152456 — CenterCross Ultra CatheterRoxwood Medical, Inc.·Product code DQY·2016-01-26
K153159 — Vinyl patient examination glove, Powder FreeXingyuan Plastic Products Co., Ltd.·Product code LYZ·2016-01-26
K151594 — Ellipse Supplemental Instrument TraysEllipse Technologies, Incorporated·Product code KCT·2016-01-25
K152137 — FacetBRIDGE SystemLdr Spine USA·Product code MRW·2016-01-25
K152503 — ImagenSPECTCardiovascular Imaging Technologies·Product code KPS·2016-01-25
K152520 — Magicore SystemInnobiosurg Co., Ltd.·Product code DZE·2016-01-25
K152977 — DG PACSDicom Grid, Inc.·Product code LLZ·2016-01-25
K153166 — Fusion BxFocal Healtcare, Inc.·Product code LLZ·2016-01-25
K153386 — Perla Posterior Cervico-Thoracic Fixation systemSpineart·Product code NKG·2016-01-25
K142541 — POCKET NEBMicrovaper Devices·Product code CAF·2016-01-22
K143042 — SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.·Product code OQU·2016-01-22
K151048 — CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient SetBracco Injeneering·Product code IZQ·2016-01-22
K151072 — Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle KitSolo-Dex, Inc.·Product code BSP·2016-01-22
K151617 — Livewire Electrophysiology CatheterSurgical Instrument Service and Savings Inc.(Dba Medline Ren·Product code NLH·2016-01-22
K151996 — TAURUS C1Shinhung Company, Ltd.·Product code EIA·2016-01-22
K152100 — Evogue Dental UnitTakara Belmont Corporation·Product code EIA·2016-01-22
K152149 — VersaOne Bladed Trocar 5mmCovidien·Product code GCJ·2016-01-22
K152400 — General & Plastic Surgery InstrumentsSontec Instruments, Inc.·Product code GCJ·2016-01-22
K152447 — ASAHI CaravelAsahi Intecc Co., Ltd.·Product code DQY·2016-01-22
K152497 — PW GuidewiresTatara Vascular, LLC·Product code DQX·2016-01-22
K152670 — DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesMedos International SARL·Product code GWM·2016-01-22
K152676 — FD TENS 2090, FD TENS 2095Fuji Dynamics , Ltd.·Product code GZJ·2016-01-22
K152741 — Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC·Product code OMP·2016-01-22
K152820 — Ponto Bone Anchored Hearing SystemOticon Medical AB·Product code MAH·2016-01-22
K152873 — Crosstella RX Balloon Dilatation CatheterKANEKA Corporation·Product code LIT·2016-01-22
K152887 — Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation·Product code LIT·2016-01-22
K153594 — MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.·Product code HCG·2016-01-22
K153679 — Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation·Product code GEI·2016-01-22
K150888 — Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc.·Product code BTY·2016-01-21
K151303 — AirLife Infant Heated Wire CircuitCare Fusion·Product code BZE·2016-01-21
K151570 — Carestation 620/650/650CDatex-Ohmeda, Inc.·Product code BSZ·2016-01-21
K152672 — Cajun Commando 4x4Lil Critter, LLC·Product code ITI·2016-01-21
K152802 — Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd.·Product code OCZ·2016-01-21
K152810 — DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC·Product code BZD·2016-01-21
K152833 — Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc.·Product code MJN·2016-01-21
K152926 — AQUACEL Ag Surgical SP DressingConvatec Limited·Product code FRO·2016-01-21
K153034 — aap LOQTEQ VA Radius Set 2.5Aap Implantate AG·Product code HRS·2016-01-21
K153381 — Corin Metafix Hip StemCorin U.S.A. Limited·Product code LZO·2016-01-21
K153402 — Discovery NM/CT 670 CZTGE Healthcare·Product code KPS·2016-01-21
K153421 — HI VISION ASCENDUS, HV ASCENDUS, ASCENDUSHitachi Aloka Medical America, Inc.·Product code IYN·2016-01-21
K153695 — Biomet Spine Fusion SystemBiomet Spine, LLC·Product code MAX·2016-01-21
K153735 — Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)·Product code NQW·2016-01-21
K151558 — Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro SystemNeurotherapies Reset GmbH·Product code KLW·2016-01-20
K151620 — Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc.·Product code KDJ·2016-01-20
K151726 — AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK SpacerStryker Corporation·Product code MAX·2016-01-20
K151959 — AirLife Infant Single Limb Heated Wire CircuitCarefusion, Inc.·Product code BZE·2016-01-20
K152241 — Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.·Product code KCT·2016-01-20
K152311 — Pentacam AXLOculus Optikgerate GmbH·Product code MXK·2016-01-20
K152352 — Stereo 3D option for Vision ApplicationsGE Medical Systems SCS·Product code LLZ·2016-01-20
K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC·Product code FWP·2016-01-20
K152473 — CAS-One IRCascination AG·Product code JAK·2016-01-20
K152584 — Stroke VCARGE Medical Systems SCS·Product code JAK·2016-01-20
K152790 — Venus Versa SystemVenus Concept , Ltd.·Product code ONF·2016-01-20
K153626 — SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.·Product code IYN·2016-01-20
K153642 — DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus MultifocalAlcon Laboratories, Inc.·Product code LPL·2016-01-20
K153643 — Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc.·Product code LPL·2016-01-20
K153672 — basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.·Product code MAV·2016-01-20
K153681 — PleuraFlow SystemClearflow, Inc.·Product code OTK·2016-01-20

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