510(k) Clearances in 2022 — Page 41

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 41 of 65)
510(k) clearancesDetails
K212327 — M-Vizion MonoblocMedacta International S.A. May 24, 2022
K213481 — Medline General Surgery TrayMedline Industries, Inc. May 24, 2022
K213659 — LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA May 24, 2022
K220191 — Disposable Face MaskJiujiang Taixin Technology Co., Ltd. May 24, 2022
DEN200062 — Parsortix PC1 DeviceAngle Europe , Ltd. May 24, 2022
K213191 — S-LineBarkey GmbH & Co. KG May 24, 2022
K221215 — e-motion M25Alber GmbH May 24, 2022
K220888 — MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. May 24, 2022
K212563 — CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/LiquidPrevest Denpro Limited May 23, 2022
K211878 — LiquiBand XLAdvanced Medical Solutions Limited May 23, 2022
K213829 — SCENARIA ViewFujifilm Healthcare Corporation May 23, 2022
K220532 — Disposable surgical maskXiamen Blue Star Enterprise Co., Ltd. May 23, 2022
K220867 — Tapestry Biointegrative ImplantEmbody, Inc. May 23, 2022
K221000 — ON3D3D Ons, Inc. May 23, 2022
K220470 — Smart Wireless StethoscopeShanghai Hulu Devices Co., Ltd. May 23, 2022
K220564 — 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 13553M Company May 23, 2022
K213402 — Triever24, Triever20Inari Medical May 23, 2022
K220507 — 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company May 23, 2022
K220155 — Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy DrugsMotex Healthcare (Anhui) Co., Ltd. May 23, 2022
K212803 — DailyMate Orthodontic Aligner System3D Global Biotech, Inc. May 23, 2022
K200788 — Assure Titanium Blood Glucose Monitoring SystemArkray, Inc. May 23, 2022
K211810 — Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)Pt. Shamrock Manufacturing Corpora May 23, 2022
K212988 — ONO Retrieval DeviceOnocor Vascular, LLC May 23, 2022
K220522 — 7D Surgical System - Percutaneous Application (7D Flash Frame)7D Surgical May 20, 2022
K220656 — iovera SystemPacira Biosciences, Inc. May 20, 2022
K211256 — Disposable Sampler Viral Transport MediaWuxi Nest Biotechnology Co., Ltd. May 20, 2022
K212752 — Med-link Pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd. May 20, 2022
K220381 — Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd. May 20, 2022
K210545 — Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machineMarci Beauty, Inc. May 20, 2022
K212979 — CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc. May 20, 2022
K220838 — Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics May 20, 2022
K220832 — syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc. May 20, 2022
K213540 — Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L May 20, 2022
K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc. May 19, 2022
K220849 — Accu-Chek Safe-T-Pro Plus Lancing DeviceRoche Diabetes Care, Inc. May 19, 2022
K220285 — PINE Pedicle Screw SystemTdm Co., Ltd. May 19, 2022
K220824 — Medical Surgical Mask (Planar type)Hunan Chopard Medical Devices Co., Ltd. May 19, 2022
K212565 — CoverScan v1Perspectum, Ltd. May 19, 2022
K220370 — Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. May 19, 2022
K220423 — PAPAYA & PAPAYA PlusGenoray Co., Ltd. May 19, 2022
K213174 — Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth May 19, 2022
K220792 — SMR Reverse LinerLima Corporate S.P.A. May 19, 2022
K211869 — OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cementOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE May 19, 2022
K220392 — PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd. May 19, 2022
K221135 — X-Twist PEEK Suture AnchorParcus Medical, LLC May 19, 2022
K210596 — ARCHITECT Toxo IgGAbbott Laboratories May 19, 2022
K221134 — Procedure Mask with Ear Loops and Surgical Mask with TiesSafesource Direct, LLC May 19, 2022
K221232 — Univers Revers Humeral Cup ImplantArthrex, Inc. May 19, 2022
K202525 — Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division May 19, 2022
K211534 — RevoLix HTLLisa Laser Products GmbH May 19, 2022
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