FDA 510(k) clearances — page 283

176,542 clearances on record, most recent first.

Clearances — page 283

28,201–28,300 of 176,542

K170454 — Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533UHonsun (Nantong) Co., Ltd.·Product code DXN·2017-10-25
K171914 — Cortina Lumbar Cage SystemNeurostructures, Inc.·Product code MAX·2017-10-25
K171946 — Gel-BeadVascular Solutions, Inc.·Product code KRD·2017-10-25
K172132 — CleanCision Wound Retraction and Protection SystemPrescient Surgical, Inc.·Product code PQI·2017-10-25
K172200 — 3880 MRI Patient Monitoring SystemIradimed Corporation·Product code MWI·2017-10-25
K172334 — Ortus Expandable Lumbar Interbody Fusion SystemAtlas Spine, Inc.·Product code MAX·2017-10-25
K172455 — CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation KitVolcano Corporation·Product code IYO·2017-10-25
K172600 — AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS MultifocalAlcon Laboratories, Inc.·Product code LPL·2017-10-25
K172617 — Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.·Product code HWC·2017-10-25
K172626 — Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous ReservoirMedtronic, Inc.·Product code DTZ·2017-10-25
K172808 — CosmoLock Pedicle Screw SystemKalitec Direct, LLC·Product code NKB·2017-10-25
K172937 — Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC·Product code FTM·2017-10-25
K172970 — M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2017-10-25
K173031 — AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.·Product code FZP·2017-10-25
K173095 — VIPER PRIME Screws, VIPER PRIME Screws with Fenestrations, EXPEDIUM® Verse Screws with FenestrationsMedos International SARL·Product code NKB·2017-10-25
K173242 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)Aziyo Biologics, Inc.·Product code FTM·2017-10-25
K170320 — Alinity c ICT Sample DiluentAbbott Laboratories·Product code CGZ·2017-10-24
K171575 — ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd.·Product code HQD·2017-10-24
K171751 — SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature ModuleCapsule Technologie Sas·Product code MWI·2017-10-24
K172000 — ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC·Product code QEZ·2017-10-24
K172251 — UTS StemUnited Orthopedic Corporation·Product code LPH·2017-10-24
K172307 — Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.·Product code OWB·2017-10-24
K172951 — Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation·Product code MQB·2017-10-24
K170056 — IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.·Product code HWC·2017-10-23
K170317 — Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories·Product code DHA·2017-10-23
K170612 — STERILE VINYL EXAMINATION GLOVES, Powder FreePrimus Gloves Pvt Limited·Product code LYZ·2017-10-23
K171001 — Monosyn Quick Synthetic Absorbable Surgical SutureAesculap, Inc.·Product code GAM·2017-10-23
K171277 — Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC·Product code DRF·2017-10-23
K171293 — G3 Active Plate® Miniature SystemGenesis Fracture Care, Inc.·Product code HRS·2017-10-23
K171489 — Acapella Cervical Spacer SystemChoicespine, LP·Product code OVE·2017-10-23
K171640 — M-ARS ACL: Anatomic Ribbon Surgery SystemMedacta International S.A.·Product code MBI·2017-10-23
K171647 — BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company , Ltd.·Product code NFO·2017-10-23
K171938 — KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic·Product code PML·2017-10-23
K171996 — TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC·Product code DXO·2017-10-23
K172213 — MECRON Cannulated Screw SystemMerete GmbH·Product code HWC·2017-10-23
K172254 — Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech·Product code LSR·2017-10-23
K172282 — Panther Fusion Paraflu AssayHologic, Inc.·Product code OOU·2017-10-23
K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.·Product code MAX·2017-10-23
K172542 — Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.Liofilchem s.r.l.·Product code JWY·2017-10-23
K172546 — AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.·Product code NKB·2017-10-23
K172585 — Liberty Anterior Cervical PlateValorus Spine·Product code KWQ·2017-10-23
K172805 — gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc.·Product code GEI·2017-10-23
K173063 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.·Product code OBJ·2017-10-23
K160405 — OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten·Product code IYE·2017-10-20
K162662 — GingiDent Gingival Retraction PastePac-Dent International, Inc.·Product code MVL·2017-10-20
K163623 — QuantraHologic, Inc.·Product code LLZ·2017-10-20
K163713 — Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation·Product code LSR·2017-10-20
K170106 — MyKnee PPS-Pin PositionersMedacta International S.A.·Product code JWH·2017-10-20
K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa·Product code KDL·2017-10-20
K170371 — DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip SyringeIntervene Group Limited·Product code PNR·2017-10-20
K170671 — SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC·Product code DRC·2017-10-20
K171052 — Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.·Product code PBX·2017-10-20
K171206 — D'Vill IntroducerNuMED, Inc.·Product code DYB·2017-10-20
K171257 — ClearPoint SystemMri Interventions, Inc.·Product code ORR·2017-10-20
K171594 — AccuroRivanna Medical, LLC·Product code IYO·2017-10-20
K171709 — BR-FHUS Viewer 1.0Taihao Medical, Inc.·Product code LLZ·2017-10-20
K171987 — Finessis Zero Flexylon Powder Free Sterile White Surgical GloveLucenxia Prescience AG·Product code KGO·2017-10-20
K172027 — Adani MammoScanAdani·Product code MUE·2017-10-20
K172090 — GuideLiner V3 CatheterVascular Solutions, Inc.·Product code DQY·2017-10-20
K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.·Product code GAP·2017-10-20
K172352 — TREFOIL SystemNobel Biocare AB·Product code DZE·2017-10-20
K172403 — GSI NovusGrason-Stadler, Inc.·Product code EWO·2017-10-20
K172869 — Discovery XR656 HDGe Hualun Medical Systems Co. , Ltd.·Product code KPR·2017-10-20
K172881 — NeuroBlate SystemMonteris Medical,·Product code GEX·2017-10-20
K173052 — Heraeus TMW GuidewireHeraeus Medical Components, LLC·Product code DQX·2017-10-20
K162216 — GRI-FILL PERISTALTIC SETLaboratorios Grifols, S.A.·Product code LHI·2017-10-19
K170261 — Premium Plus Prophy Air MotorPremium Plus International Limited·Product code EFB·2017-10-19
K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott Laboratories·Product code CFR·2017-10-19
K170453 — Medrobotics Flex Robotic SystemMedrobotics Corporation·Product code EOB·2017-10-19
K170614 — CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemI-Sens, Inc.·Product code NBW·2017-10-19
K171014 — VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH·Product code OOE·2017-10-19
K171243 — audifon Tinnitus-ModuleAudiofon USA, Inc.·Product code KLW·2017-10-19
K171672 — 065 Zenith, 074 ZenithInneuroco, Inc.·Product code DQY·2017-10-19
K171774 — RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.·Product code NPK·2017-10-19
K172079 — AvailOmron Healthcare, Inc.·Product code NUH·2017-10-19
K172281 — PuRE PMMA DiscQuest Dental USA Corp.·Product code EBG·2017-10-19
K172376 — Discovery Pico, Discovery Pico PlusQuanta System Spa·Product code GEX·2017-10-19
K172527 — Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque StripeCook Incorporated·Product code LJE·2017-10-19
K172811 — EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.·Product code ODE·2017-10-19
K170298 — Liberator Beacon Tip Locking StyletCook Incorporated·Product code DRB·2017-10-18
K171017 — Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16TConvaid Products, LLC·Product code IOR·2017-10-18
K171068 — OrthoView 7.2Meridian Technique, Ltd.·Product code LLZ·2017-10-18
K171125 — Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact LensTangible Science, LLC·Product code LPL·2017-10-18
K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2017-10-18
K172034 — Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato TapStryker Corporation·Product code OLO·2017-10-18
K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC·Product code MLY·2017-10-18
K172297 — NovaCross MicrocatheterNitiloop , Ltd.·Product code DQY·2017-10-18
K172608 — Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesSurgical Instrument Service and Savings, Inc.·Product code NUJ·2017-10-18
K172801 — ECG SENTINEL SystemCardiomedix, Inc.·Product code DXH·2017-10-18
K172809 — OTC Combo TENS/EMS SystemWell-Life Healthcare Limited·Product code NUH·2017-10-18
K172910 — Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc.·Product code DJG·2017-10-18
K172940 — ANCHOR Tissue Retrieval SystemConmed Corporation·Product code GCJ·2017-10-18
K173101 — Curve Image 2.0 PACSCurve Dental, Ltd.·Product code LLZ·2017-10-18
K160282 — SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home SystemSd Biosensor·Product code NBW·2017-10-17
K170538 — RVS-100 Vital Signs MonitorRudolf Riester GmbH·Product code MWI·2017-10-17
K170834 — CERABIEN ZRKuraray Noritake Dental, Inc.·Product code EIH·2017-10-17
K171752 — X-SURGEGenicon, Inc.·Product code GEI·2017-10-17
K172179 — Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.·Product code LYA·2017-10-17
K172198 — 585Quanta System Spa·Product code GEX·2017-10-17
K172493 — EnsoETMAttune Medical·Product code PLA·2017-10-17

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