510(k) Clearances in 2022 — Page 28

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 28 of 65)
510(k) clearancesDetails
K213645 — ClearPoint Maestro Brain ModelClearPoint Neuro, Inc. Aug 8, 2022
K221668 — Dental Impression MaterialChemoment Materials Co.,Ltd Aug 8, 2022
K213735 — dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips) Aug 8, 2022
K213727 — dS Sentinelle Breast 16ch 3.0T CoilInvivo Corporation (Business Trade Name: Philips) Aug 8, 2022
K213934 — Pro Guard Nitrile Powder Free Examination GloveMedical Glove Co., Ltd. Aug 6, 2022
K221854 — Reprocesses Umbilical CableInnovative Health, LLC Aug 6, 2022
K213876 — Spineology Navigation InstrumentsSpineology, Inc. Aug 5, 2022
K213791 — Unispace SA Cervical CageEdisoninno Co., Ltd. Aug 5, 2022
K213993 — Powder Free Chloroprene Examination Glove Coloured (Blue, Green)Careglove Global Sdn. Bhd. Aug 5, 2022
K221350 — Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)Rubberex Alliance Products Sdn Bhd Aug 5, 2022
K220045 — TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd. Aug 5, 2022
K221336 — AvéliRevelle Aesthetics, Inc. Aug 5, 2022
K212810 — MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd. Aug 5, 2022
K221405 — Neurophet SCALE PETNeurophet., Inc. Aug 5, 2022
K220576 — FAMA Male Latex CondomsShanghai Personage Hygiene Products Co., Ltd. Aug 5, 2022
K221952 — Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation Aug 4, 2022
K220303 — MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaid Aug 4, 2022
K211614 — CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. Aug 4, 2022
K221628 — exGraft, exGraft CarbonPeca Labs Aug 4, 2022
K221124 — MANTIS ClipBoston Scientific Corporation Aug 4, 2022
K220887 — Mini-ClotTriever Thrombectomy SystemInari Medical Aug 4, 2022
K220524 — Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited Aug 4, 2022
K221328 — Bloomi Smooth Water Based LubricantThe Bloomi Inc.. Aug 4, 2022
K221104 — Actera™ hip systemConformis, Inc. Aug 4, 2022
K220001 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc. Aug 4, 2022
K221953 — Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation Aug 4, 2022
K213614 — Cannulated ScrewsMaxxion Medical, LLC Aug 3, 2022
K213477 — Root ZX3J. Morita USA, Inc. Aug 3, 2022
K220139 — QScreenPath Medical GmbH Aug 3, 2022
K221347 — Transpara 1.7.2Screenpoint Medical B.V. Aug 3, 2022
K221432 — Customize3D-Side S.A. Aug 3, 2022
K191131 — Solidence MultipocketsSolidence Surgical Corporation Aug 3, 2022
K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seedPhadia AB Aug 3, 2022
K220816 — BruxZir NOWPrismatik Dentalcraft, Inc. Aug 2, 2022
K210179 — QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc. Aug 2, 2022
K220032 — iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation Aug 2, 2022
K220237 — Disposable Medical Nitrile Examination GlovesFujian Jixiang Medical Technology Co.,Ltd Aug 1, 2022
K213929 — Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidO&M Halyard, Inc. Aug 1, 2022
K221549 — X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd. Aug 1, 2022
K220736 — Consolidated HC Steam SterilizerConsolidated Machine Corp. Aug 1, 2022
K221671 — CellFX® SystemPulse Biosciences, Inc. Aug 1, 2022
K221616 — Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc. Aug 1, 2022
K221451 — IPL hair removalShenzhen Lizbella Technology Co.,Ltd Aug 1, 2022
K221773 — Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric AcidOnetexx Sdn Bhd Jul 30, 2022
K220901 — S-Core Implant SystemSubchondral Solutions, Inc. Jul 29, 2022
K220566 — Vascette HP (hemostatic pad)Koag, LLC Jul 29, 2022
K221242 — Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHunan Vsmile Biotechnology Co., Ltd. Jul 29, 2022
K220733 — OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas) Jul 29, 2022
K202852 — DiviTum TKaBiovica International AB Jul 29, 2022
K220048 — NobelProcera Zirconia N1 BaseNobel Biocare Services AG Jul 29, 2022
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