510(k) Clearances in 2022 — Page 25

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 25 of 65)
510(k) clearancesDetails
K221325 — CONDUIT Lateral Switch PlateMedos International SARL Aug 25, 2022
K221648 — Iconic Latex GloveIconic Medicare Sdn Bhd Aug 25, 2022
K211298 — WiEMSproMedical Cables S.L. Aug 25, 2022
K221962 — LINQ II Insertable Cardiac MonitorMedtronic, Inc. Aug 25, 2022
K222543 — AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorSteris Aug 25, 2022
K221206 — Compass Steerable NeedleSerpex Medical, Inc. Aug 25, 2022
K221792 — Acute QC Strut and ComponentsSmith & Nephew, Inc. Aug 25, 2022
K221427 — V-LaserWontech Co., Ltd. Aug 24, 2022
K212784 — TightRail Guardian Motorized Dilator SheathSpectranetics, Inc. Aug 24, 2022
K222230 — NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental HealthNeuronetics, Inc. Aug 24, 2022
K211771 — The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical MaskThe Good Corporation Aug 24, 2022
K220598 — AutoContour Model RADAC V2Radformation, Inc. Aug 24, 2022
K221920 — ARIX Small Fragment SystemJeil Medical Corporation Aug 24, 2022
K222232 — Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyBard Access Systems, Inc. Aug 24, 2022
K222212 — ivWatch Model 400Ivwatch, LLC Aug 24, 2022
K222236 — miCOR System Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology, Inc. Aug 24, 2022
K220998 — Transcutaneous Electrical Nerve Stimulator, Model: KTR-405Shenzhen Kentro Medical Electronics Co., Ltd. Aug 24, 2022
K220061 — Safety Insulin SyringesBerpu Medical Technology Co., Ltd. Aug 23, 2022
K213072 — 2.1 x 255mm Drill, 22mm StopBiomet Micofixation Aug 23, 2022
K221850 — GMK 3D Metal Tibial TrayMedacta International S.A. Aug 23, 2022
K220583 — ClearCheck Model RADCC V2Radformation, Inc. Aug 23, 2022
K220268 — Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd. Aug 23, 2022
K221546 — OneTouch Delica Plus Lancing SystemAsahi Polyslider Co., Ltd. Aug 23, 2022
K222274 — FONA XDCFona S.R.L Aug 23, 2022
K220640 — Bifix Hybrid Abutment CementVoco GmbH Aug 23, 2022
K213803 — FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc. Aug 23, 2022
K220603 — Disposable Medical Safety Hypodermic NeedleHantech Medical Device Co., Ltd. Aug 23, 2022
K222257 — 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilInvivo Corporation (Business Trade Name: Philips) Aug 23, 2022
K211601 — Powder Free Latex Examination Glove, Non-SterileWrp Asia Pacific Sdn. Bhd. Aug 22, 2022
K201730 — Powered Inflatable Tube Massager - SLIM UP DRAINFoggiare Technologies, LLC Aug 22, 2022
K221485 — Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. Aug 22, 2022
K221835 — CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation Aug 22, 2022
K221604 — SafetiHeel, MediHeel, NovaplusNsp Tech Pte, Ltd. Aug 22, 2022
K213109 — Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited Aug 22, 2022
K221599 — HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Aug 22, 2022
K220363 — VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A Subsidiary Of Teleflex, Inc.) Aug 22, 2022
K212095 — SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V. Aug 22, 2022
K221528 — Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy CatheterEdwards Lifesciences, LLC Aug 22, 2022
K221832 — SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterCordis US Corp Aug 22, 2022
K220582 — ClearCalc Model RADCA V2Radformation, Inc. Aug 22, 2022
K221917 — Stent Positioning Assistance System (SPAS)Seven Sons , Ltd. Aug 19, 2022
K220812 — DynaClip® Bone StapleMedShape, Inc. Aug 19, 2022
K222172 — MI View&GOSiemens Medical Solutions USA, Inc. Aug 19, 2022
K213933 — Percent Oxygen SensorsCareox, LLC Aug 19, 2022
K222239 — SmartBolus CalculatorInsulet Corporation Aug 19, 2022
K212554 — Bonvadis Topical CreamStemcyte, Inc. Aug 19, 2022
K220696 — uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA Aug 19, 2022
K220394 — SmartAdjust(TM) technologyInsulet Corporation Aug 19, 2022
K221224 — REAL INTELLIGENCE CORIBlue Belt Technologies, Inc. Aug 19, 2022
K221238 — FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation Aug 19, 2022
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