510(k) Clearances in 2021 — Page 60

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 60 of 61)
510(k) clearancesDetails
K201700 — BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG Jan 13, 2021
K203639 — StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc. Jan 13, 2021
K201014 — MyOnyx SystemThought Technology , Ltd. Jan 13, 2021
K192933 — Polyisoprene Powder Free, Black Colour Surgical GlovesEmerson & Co. Srl Jan 13, 2021
K200609 — ENTity WiFi Video Nasopharyngoscope SystemOptim, LLC Jan 13, 2021
K203671 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. Jan 13, 2021
K203105 — Inion CompressOn ScrewInion OY Jan 13, 2021
K202314 — Procedure face mask (Model: KKF-2A)Han Zhaoqing Sporting Goods Company Limited Jan 13, 2021
K202843 — Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. Jan 12, 2021
K203658 — Micro C Medical Imaging System, M01Oxos Medical, Inc. Jan 12, 2021
K203280 — Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd. Jan 12, 2021
K203526 — C Scope Visualization SystemCit Ortho Jan 12, 2021
K201836 — Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation Jan 12, 2021
K203201 — NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF SystemNu Vasive, Incorporated Jan 12, 2021
K203129 — NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc. Jan 12, 2021
K201625 — Disposable Medical Surgical MaskTianjin Saiyuan Technology Co., Ltd. Jan 12, 2021
K201241 — Striate+™Orthocell, Ltd. Jan 11, 2021
K203231 — Switched Internal PaddlesPhilips North America, LLC Jan 11, 2021
K201471 — M-Vizion Femoral Revision System ExtensionMedacta International S.A. Jan 11, 2021
K202577 — Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd. Jan 11, 2021
K202505 — GetSet Surgical GoPLF! Posterior Lateral Fusion SystemGetset Surgical, SA Jan 11, 2021
K203397 — Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cmBiopsybell S.R.L. Jan 11, 2021
K193079 — ICE COMPRESSION FIRST, DUO, & MOOVE SystemsMks Paris Jan 11, 2021
K200717 — CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical , Ltd. Jan 9, 2021
K202874 — Puritan Bennett Cuff Pressure ManagerCovidien, LLC Jan 9, 2021
K202017 — Passion Natural Water Based LubricantXr, LLC Jan 8, 2021
K202278 — OBS Anchorage Screw, Biokey Anchorage ScrewBomei Co, Ltd. Jan 8, 2021
K203114 — LOGIQ P10, LOGIQ P9, LOGIQ P8GE Medical Systems Ultrasound And Primary Care Diagnostics Jan 8, 2021
K203630 — BioGuard Air/Water and Suction ValvesSteris Corporations Jan 8, 2021
K203329 — HeartFlow AnalysisHeartFlow, Inc. Jan 8, 2021
K202291 — Button LoopYunyi (Beijing) Medical Device Co., Ltd. Jan 8, 2021
K203341 — ACS LD Uni FB Knee SystemImplantcast GmbH Jan 8, 2021
K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc Jan 8, 2021
K202721 — Celerity 20 Steam Biological Indicator for IUSSSTERIS Corporation Jan 8, 2021
K201778 — i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories Jan 8, 2021
K200918 — SurgiWrap FROSTMast Biosurgery Jan 7, 2021
K202405 — BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jan 7, 2021
K203117 — TissueTak deviceVia Surgical , Ltd. Jan 7, 2021
K203345 — MULTIX ImpactSiemens Medical Solutions USA, Inc. Jan 7, 2021
K202544 — Instylla Delivery KitInstylla, Inc. Jan 7, 2021
K202488 — ZSFab Cervical Interbody SystemZsfab, Inc. Jan 7, 2021
K202414 — BrainInsightHyperfine Research, Inc. Jan 7, 2021
K201577 — MatriDermMedskin Solutions Dr. Suwelack AG Jan 7, 2021
K202622 — Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl CitrateO&M Halyard, Inc. Jan 7, 2021
K203652 — Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740DJkh USA, LLC Jan 6, 2021
K200021 — Applied Medical AnoscopeApplied Medical Resources Jan 6, 2021
K203465 — OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated DesignOSSIO , Ltd. Jan 6, 2021
K202350 — SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) Jan 6, 2021
K202491 — Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd. Jan 6, 2021
K203339 — NEOLab Clear AlignersNew England Ortho Lab, Inc. Jan 6, 2021
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