510(k) Clearances in 2021 — Page 18

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 18 of 61)
510(k) clearancesDetails
K212328 — DiscCath Needle SetDisccath, LLC Sep 26, 2021
K202459 — Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/FilterPharma System AB Sep 26, 2021
K201592 — Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveCardinal Health200, LLC Sep 26, 2021
K203731 — DT100 Digital ThermometerSmart Technology Co., Ltd. Sep 26, 2021
K210908 — Surgical MaskSichuan Prius Biotechnology Co., Ltd. Sep 26, 2021
K212099 — Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd. Sep 24, 2021
K211505 — Encore Hip StemSignature Orthopaedics Pty, Ltd. Sep 24, 2021
K210857 — Personal LubricantShenzhen Huanqiu Xuebao Technology Co., Ltd. Sep 24, 2021
K212725 — ViperCross Support CathetersCardiovascular Systems, Inc. Sep 24, 2021
K212557 — Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC Sep 24, 2021
K202618 — IV Administration SetsB.Braun Medical, Inc. Sep 24, 2021
K212108 — Dynamic TiBaseTalladium España, SL Sep 24, 2021
K212777 — Collaboration LivePhilips Ultrasound, Inc. Sep 24, 2021
K211973 — DRI Cocaine Metabolite AssayMicrogenics Corporation Sep 24, 2021
K212704 — Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems Sep 24, 2021
K212125 — Nobel Biocare Dental Implant Systems Portfolio - MR ConditionalNobel Biocare AG Sep 24, 2021
K210232 — Sterile Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. Sep 23, 2021
K212002 — Synthetic Vinyl Examination GlovesYunnan Huazhiyuan Medical Technology Co., Ltd. Sep 23, 2021
K211667 — Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. Sep 23, 2021
K202092 — ABC Dental Implant SystemAbracadabra Implants , Ltd. Sep 23, 2021
K210707 — OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare , Ltd. Sep 23, 2021
K212792 — Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageMedynus, Inc. Sep 23, 2021
K212728 — Standard Bougie, 38 Fr. and Hand PumpStandard Bariatrics Sep 23, 2021
K210294 — One Touch Spiral CondomThai Nippon Rubber Industry Public Company Limited. Sep 23, 2021
K211747 — Reusable NIBP CuffShenzhen Coreray Technology Co., Ltd. Sep 23, 2021
K203446 — TorrentX Wound WashNext Science, LLC Sep 23, 2021
K211996 — Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc. Sep 23, 2021
K203662 — Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11Yibin Junxin Electronics Technology Co., Ltd. Sep 23, 2021
K211827 — Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd. Sep 23, 2021
K212321 — JiveX (Model Number / Release: 5.3)Visus Health IT GmbH Sep 23, 2021
K210152 — Automatic Digital Blood Pressure MonitorAviche Shandong Medical Technology Co, Ltd. Sep 23, 2021
K212708 — Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. Sep 23, 2021
K212411 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)Conformis, Inc. Sep 23, 2021
K211974 — LED PHOTIC SystemMicromed S.P.A. Sep 23, 2021
K212342 — ZIIP+ DeviceZiip, Inc. Sep 23, 2021
K212353 — DB-EZ Bone Void FillerDimensional Bioceramics, LLC Sep 22, 2021
K212727 — FilmArray Pneumonia PanelBiofire Diagnostics, LLC Sep 22, 2021
K211805 — IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody SystemAlphatec Spine, Inc. Sep 22, 2021
K210045 — ACTIVA PRESTO PACKPulpdent Corporation Sep 22, 2021
K211097 — Banyan USA Surgical Mask Level 3Banyan USA, LLC Sep 22, 2021
K210772 — 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)Vr Vertical, LLC Dba Xrgo Sep 22, 2021
K210263 — Mpres Neck Preserving StemMedacta International S.A. Sep 22, 2021
K212667 — Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp. Sep 22, 2021
K212660 — Smylio Invisible Clear AlignersSmylio, Inc. Sep 22, 2021
K212160 — SimpleSENSE PlatformNanowear, Inc. Sep 22, 2021
K200423 — Electric Wheelchair (XW-LY001)Yongkang Dingchang Industry & Trade Co., Ltd. Sep 22, 2021
K212692 — Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation Sep 21, 2021
DEN200080 — Paige ProstatePaige.Ai Sep 21, 2021
K211689 — KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd. Sep 21, 2021
K212287 — Dayspring LiteKoya Medical, Inc. Sep 21, 2021
← Previous Page 18 of 61 Next →