510(k) Clearances in 2022 — Page 62

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 62 of 65)
510(k) clearancesDetails
K212748 — Disposable Dual Action Tissue ClipMicro-Tech (Nanjing) Co., Ltd. Jan 20, 2022
K212592 — Gas-Chex IndicatorPropper Manufacturing Co., Inc. Jan 20, 2022
K203161 — Surgical Face MaskWuhan Raytex Protection Co., Ltd. Jan 20, 2022
K212357 — Surgical isolation gownWuhan Zonsen Medical Products Co., Ltd. Jan 20, 2022
K212941 — Porous PatellaEncore Medical, L.P. Dba Djo Surgical Jan 20, 2022
K212884 — Electric breast pumpDongguan Rongfeng Medical Co., Ltd. Jan 20, 2022
K214084 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. Jan 20, 2022
K212458 — Flexible Video-Uretero-Renoscope SSU SystemKarl Storz Endoscopy America Jan 20, 2022
K213356 — Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. Jan 20, 2022
K214019 — syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. Jan 20, 2022
K212581 — VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH Jan 19, 2022
K211330 — R3 Large Head LinersSmith & Nephew, Inc. Jan 19, 2022
K211532 — Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33Yibin Junxin Electronics Technology Co., Ltd. Jan 19, 2022
K203072 — Franz Zirconia Dental CrownFranz Biotech, Inc. Jan 19, 2022
K213447 — LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.Shenzhen Cosbeauty Technology Co., Ltd. Jan 19, 2022
K212683 — GLOBAL ICON Stemless Shoulder SystemDepuy(Ireland) Jan 19, 2022
K211613 — Stern Fix Sternal Stabilization SystemNeos Surgery S.L Jan 19, 2022
K212012 — Follicle ClarityCycle Clarity Jan 19, 2022
K213424 — Jabra Enhance PlusGN Hearing A/S Jan 19, 2022
K212826 — Disposable Medical MaskJiangsu Nanfang Medical Co., Ltd. Jan 19, 2022
K213227 — Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)Uweport, LLC Jan 19, 2022
K211003 — SHOWA(R) Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc. Jan 19, 2022
K214059 — CoreLink Navigation InstrumentsCorelink, LLC Jan 19, 2022
K211709 — BiotresBiotricity Jan 19, 2022
K212650 — Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. Jan 19, 2022
K213438 — 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy AccessoryAdaptiiv Jan 19, 2022
K212576 — MDx-Chex for BCID2Streck, Inc. Jan 19, 2022
K210747 — Caption Interpretation Automated Ejection Fraction SoftwareCaption Health Jan 19, 2022
K213781 — ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC Jan 18, 2022
K213216 — Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact LensUnicon Optical Co., Ltd. Jan 18, 2022
K212713 — Air compression leg massager HY-1117AXiamen High Top Electronic Technology Co., Ltd. Jan 18, 2022
K213572 — JuniOrtho Plating System™Orthofix Srl Jan 18, 2022
K212842 — Microvolume Luer Access DeviceB.Braun Medical, Inc. Jan 18, 2022
K212503 — HP458E Electrically Powered WheelchairKunshan Hi-Fortune Health Products Co., Ltd. Jan 18, 2022
K201044 — CHIRANA Insulin SyringesChirana T. Injecta Jan 18, 2022
K210679 — Medical Face MaskWuxi Yushou Medical Appliances Co., Ltd. Jan 18, 2022
K212994 — Medical Face MaskGuangzhou Quantum Laser Intelligent Equipment Co., Ltd. Jan 17, 2022
K213920 — Kangbeier Surgical Mask (Model: KBR-1001)Xinxiang Kangbeier Medical Technology Co., Ltd. Jan 16, 2022
K211980 — SIGNA PrimeGe Healthcare (Tianjin) Company Limited Jan 16, 2022
K211833 — Disposable Medical Face MaskZhejiang The Purples Protective Products Co.,Ltd Jan 16, 2022
K211360 — Disposable Nitrile Powder Free Examination Gloves (Non-sterile)Pt. Universal Gloves Jan 15, 2022
K212772 — Precision AlignPrecision Align, LLC Jan 15, 2022
K211814 — Wellead Endoscopic SealWell Lead Medical Co., Ltd. Jan 14, 2022
K213335 — Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. Jan 14, 2022
K203773 — BRM TOOL ScrewsBrm Extremities Srl Jan 14, 2022
K213602 — Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, LLC Jan 14, 2022
K202783 — Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited Jan 14, 2022
K213593 — OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation Jan 14, 2022
K213643 — UltraPrint-Dental Temp C&B UVGuangzhou Heygears IMC., Inc. Jan 14, 2022
K213927 — Respiratory Gating for Scanners v2.0Varian Medical Systems, Inc. Jan 14, 2022
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