510(k) Clearances in 2021 — Page 34

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 34 of 61)
510(k) clearancesDetails
K210044 — Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal SystemSpinal Elements, Inc. Jun 30, 2021
K203057 — Quantum Perfusion Arterial Cannula GraftQura S.R.L Jun 30, 2021
K211025 — Oral/Enteral Syringe with ENFit connectorNingbo Tianyi Medical Appliance Co., Ltd. Jun 30, 2021
K210904 — Metapaste PlusMeta Biomed Co., Ltd. Jun 30, 2021
K203717 — Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton Jun 30, 2021
K201206 — Pivot Breath SensorCarrot, Inc. Jun 30, 2021
K211768 — LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG Jun 30, 2021
K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 CardiographPhilips Medical Systems Jun 30, 2021
K210377 — Stryker iBur hubs and cutting accessoriesStryker Corporation Jun 30, 2021
K210512 — LUMINELLE DTx SystemUvision360, Inc. Jun 30, 2021
K210645 — RayStation 10.1RaySearch Laboratories AB (PUBL) Jun 29, 2021
K210954 — SynergyYrs Group, Inc. Jun 29, 2021
K210843 — STAGESpintech, Inc. Jun 29, 2021
K210837 — Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. Jun 29, 2021
K210445 — Nordiwell Surprotect Face MaskChangzhou Combat Protective Equipment Co., Ltd. Jun 29, 2021
K203645 — Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40Supersonic Imagine Jun 29, 2021
K210437 — Standard Bougie, 38 Fr.Standard Bariatrics Jun 29, 2021
K203733 — 12MP Color Digital Mammography LCD Monitor CL-S1200Jvckenwood Corporation Jun 29, 2021
K211038 — Biophotas Celluma RESTOREBiophotas, Inc. Jun 29, 2021
K210587 — Violet Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd Jun 28, 2021
K210421 — Diafil & Diafil CapsuleDiaDent Group International Jun 28, 2021
K210775 — White Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd Jun 28, 2021
K210869 — Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. Jun 28, 2021
K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. Jun 28, 2021
K203410 — ENFit Disposable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd Jun 28, 2021
K210889 — iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation Jun 25, 2021
K203657 — Vu-Path Ultrasound SystemCrystalline Medical Jun 25, 2021
K211193 — BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) Jun 25, 2021
K211293 — Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd. Jun 25, 2021
K201196 — Scooter (Model: FDB01)Nanjing Jin Bai HE Medical Apparatus Co., Ltd. Jun 25, 2021
K210098 — PuraStat-GI3-D Matrix, Inc. Jun 25, 2021
K210138 — iTind SystemMedi-Tate , Ltd. Jun 25, 2021
K211656 — 3D Echo v1.1Jointvue, LLC Jun 25, 2021
K211232 — Apache Ultrasound SystemAco Healthcare Co., Ltd. Jun 25, 2021
K211252 — Nitrile GloveJiangsu Dihong Industry And Trade Co., Ltd. Jun 25, 2021
K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics Corporation Jun 25, 2021
K211238 — SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone CementStryker Instruments Jun 25, 2021
K210423 — Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandArthroCare Corporation Jun 24, 2021
K210959 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jun 24, 2021
K201428 — Powder Free Black Nitrile Examination GloveVietglove Corporation Jun 24, 2021
K211191 — Virtual C DRF Digital Imaging SystemPortavision Medical, LLC Jun 24, 2021
K210656 — ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsCareplus (M) Sdn Bhd Jun 24, 2021
K211306 — LABYRINTHZavation Medical Products, LLC Jun 24, 2021
K203375 — OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc. Jun 24, 2021
K202523 — TMJ RelaxMoonwalker Innovations, Inc. Jun 24, 2021
K202551 — Cor-Knot MicroLsi Solutions, Inc. Jun 24, 2021
K211259 — Renamel BulkfillCosmedent, Inc. Jun 24, 2021
K202897 — Natural CyclesNatural Cycles Nordic AB Jun 24, 2021
K211297 — SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments Jun 24, 2021
K210909 — easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd. Jun 24, 2021
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