510(k) Clearances in 2021 — Page 57

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 57 of 61)
510(k) clearancesDetails
K202627 — Medical Face MasksGuilin Hbm Sanitary Protections, Inc. Feb 3, 2021
K202027 — Balex bone Expander SystemTaeyeon Medical Co., Ltd. Feb 3, 2021
K203294 — Arthrex Pilon Fusion SystemArthrex, Inc. Feb 3, 2021
K200301 — UNiTi ACDF Implant SystemPressio, Inc. Feb 3, 2021
K200636 — AXUS ES-5 Electro-Acupuncture DeviceLhasa Oms, Inc. Feb 3, 2021
K193422 — Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. Feb 2, 2021
K203634 — BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC Feb 2, 2021
K203299 — CellFX SystemPulse Biosciences, Inc. Feb 2, 2021
K203667 — EzRay M (Model: VMX-P300)VATECH Co., Ltd. Feb 2, 2021
K201231 — CTxx85 CT ScannerAnalogic Corporation Feb 2, 2021
K202331 — Medical Face MaskGemtier Medical (Shanghai), Inc. Feb 2, 2021
K203278 — INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA SpacersGlobus Medical, Inc. Feb 2, 2021
K202097 — Fundus CameraHuvitz Co., Ltd. Feb 2, 2021
K202323 — Disposable Medical Surgical MasksTianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. Feb 2, 2021
K203553 — Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Feb 2, 2021
K202096 — 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-OnEcoguard, Inc. Feb 2, 2021
K202511 — Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd. Feb 2, 2021
K203568 — Hoffmann LRF SystemStryker GmbH Feb 1, 2021
K203537 — Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsSedecal., Sa. Feb 1, 2021
K203483 — Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc. Feb 1, 2021
K203794 — HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL Feb 1, 2021
K203603 — Monopolar HookHuman Xtensions , Ltd. Feb 1, 2021
K203393 — FAST-FIX FLEXSmith & Nephew, Inc. Feb 1, 2021
K202366 — MAGIC Infusion CatheterBalt USA, LLC Jan 29, 2021
K201752 — Disposable Pre-calibrated SuctionBrainlab AG Jan 29, 2021
K192650 — i_Space 1.5T Superconducting Magnetic Resonance Imaging SystemMri Division,Beijing Wandong Medical Technology Co., Ltd. Jan 29, 2021
K203531 — XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. Jan 29, 2021
K202310 — Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full BackWildcat Ppe, LLC Jan 29, 2021
K201620 — Luna® G3 BPAP 25A3B Medical, Inc. Jan 29, 2021
K202282 — Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. Jan 29, 2021
K200429 — BEE CagesNGMedical GmbH Jan 29, 2021
K191878 — DEX DeviceDex Surgical Jan 29, 2021
K190677 — EndoClotEndoclot Plus Co., Ltd. Jan 29, 2021
K201993 — E-connect S Endo Motor with built-in Apex LocatorChangzhou Sifary Medical Technology Co., Ltd. Jan 29, 2021
K201411 — Visage Breast DensityVisage Imaging GmbH Jan 29, 2021
K202221 — VX650Luneau Technology Operations Jan 29, 2021
K202970 — Ventway SparrowInovytech Medical Solutions , Ltd. Jan 29, 2021
K202878 — Prase-AP Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. Jan 29, 2021
K201418 — Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc. Jan 29, 2021
K202398 — Ti3Z Cervical Interbody SystemZavation Medical Products, LLC Jan 29, 2021
K201838 — PediFlex Flexible Nail SystemOrthoPediatrics Corp. Jan 29, 2021
K201801 — Rapid Acoustic Pulse DeviceSoliton, Inc. Jan 29, 2021
K202358 — Protective Face Mask for Medical UseHunan Heng Chang Pharmaceutical Co., Ltd. Jan 29, 2021
K203220 — cobas BKVRoche Molecular Systems, Inc. Jan 29, 2021
K202754 — MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH Jan 28, 2021
K203840 — BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC Jan 28, 2021
K203507 — Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. Jan 28, 2021
K202892 — Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc. Jan 28, 2021
K203474 — Biomet Microfixation RibFix Advantage SystemBiomet Micofixation Jan 28, 2021
K200289 — Michler-Kapp Cardiovascular Vent CatheterKapp Surgical Instrument, Inc. Jan 28, 2021
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