510(k) Clearances in 2021 — Page 38

3,023 510(k) clearances total

Browse FDA 510(k) clearances granted in 2021. RegDataLab tracks 3,023 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2021 (page 38 of 61)
510(k) clearancesDetails
K210652 — 6MS Invisible AlignerSms Opco, LLC Jun 2, 2021
K210429 — Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd. Jun 2, 2021
K200891 — BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson And Company Jun 2, 2021
K210150 — Disposable Medical maskHubei Wanli Protective Products Co., Ltd. Jun 2, 2021
K210583 — SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation Jun 2, 2021
K211051 — DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes Jun 2, 2021
K203229 — NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllergan Jun 2, 2021
K210994 — Arthrex Beveled FT ScrewsArthrex, Inc. Jun 1, 2021
K200942 — Well-Life Garment Electrodes (GM Series)Well-Life Healthcare Limited Jun 1, 2021
K210025 — INVU by NuvoNuvo- Group , Ltd. May 28, 2021
K211344 — MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery SystemsMedos International SARL May 28, 2021
K211304 — LINQ II Insertable Cardiac MonitorMedtronic, Inc. May 28, 2021
K200607 — LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG May 28, 2021
K210188 — coraCrossReflow Medical May 28, 2021
K203687 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction IndexEdwards Lifesciences, LLC May 28, 2021
K210536 — Irrisept Antimicrobial Wound LavageIrrimax Corporation May 28, 2021
K210289 — Infant Phototherapy EquipmentBistos Co., Ltd. May 28, 2021
K210917 — Single Use Injection NeedleAnrei Medical (Hangzhou) Co., Ltd. May 28, 2021
K211311 — AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. May 28, 2021
K211261 — Axis Charcot Fixation SystemExtremity Medical, LLC May 28, 2021
K202932 — ABT12 multi-purpose solutionBausch & Lomb, Incorporated May 28, 2021
K211301 — Pathfinder Endoscope OvertubeNeptune Medical, Inc. May 28, 2021
K211134 — BIB Stent Placement CatheterNuMED, Inc. May 27, 2021
K211282 — Aqua Medical RF Vapor SystemAqua Medical, Inc. May 27, 2021
K200704 — ZedViewLexi Co., Ltd. May 27, 2021
K201639 — Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and ReloadsBeijing Biosis Healing Biolog Ical Technology Co., Ltd. May 27, 2021
K211057 — LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc. May 27, 2021
DEN190043 — SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical May 27, 2021
K202765 — ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugsCareplus (M) Sdn Bhd May 27, 2021
K211307 — GalaSTITCH Absorbable Monofilament SutureTepha, Inc. May 27, 2021
K202832 — Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda May 26, 2021
K211292 — Fassier-Duval Telescopic IM SystemPega Medical, Inc. May 26, 2021
K211098 — Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc. May 26, 2021
K210520 — Disposable Synthetic Examination GlovesShandong Shengshixincheng Medical Science & Technology Co., May 26, 2021
K203322 — SpyGlass Discover Retrieval BasketBoston Scientific Corporation May 26, 2021
K211258 — Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody SystemMedtronic Sofamor Danek USA, Inc. May 26, 2021
K210051 — OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC May 26, 2021
K203196 — Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd. May 26, 2021
K211251 — ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc. May 26, 2021
K211253 — PlasmaWaveManamed, Inc. May 26, 2021
K211460 — Air Relax Plus Model AR-3.0Diode Art Engineering Doing Business AS Air Relax May 25, 2021
K203724 — HeRO Graft, HeRO AdapterMerit Medical Systems, Inc. May 25, 2021
K211275 — AirMax Procedure MaskPremiumestore, LLC May 25, 2021
K210608 — LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation May 25, 2021
K203760 — Tokuyama Universal Bond IITokuyama Dental Corporation May 25, 2021
K210977 — E-Dent 1000Envisiontec GmbH May 25, 2021
K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC May 25, 2021
K210915 — Pathfinder Endoscope CapNeptune Medical, Inc. May 25, 2021
K203144 — MicroPen EVOEclipse Medcorp, LLC May 25, 2021
K210425 — Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. May 24, 2021
← Previous Page 38 of 61 Next →