510(k) Clearances in 2021 — Page 7

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 7 of 61)
510(k) clearancesDetails
K202175 — OxyLight 2.0Raja Trading Company, Inc. Dec 2, 2021
K211886 — Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co. , Ltd. Dec 2, 2021
K212789 — Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)5R Med Instruments (Chengdu) Co., Ltd. Dec 1, 2021
K213305 — Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Dec 1, 2021
K211755 — Electric Breast PumpZhejiang Carebao Co., Ltd. Dec 1, 2021
K211959 — Milli Vaginal DilatorMaterna Medical Dec 1, 2021
K212050 — NGM WAVE PLIF CageNGMedical GmbH Dec 1, 2021
K212804 — Powder free nitrile examination glove- blue, non-sterileHong Seng Gloves Sdn Bhd Dec 1, 2021
K212864 — dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd. Dec 1, 2021
K212326 — AC Cream - Conductive pasteSpes Medica Srl Dec 1, 2021
K210934 — Sphincterotome / short-wire compatible, Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd. Dec 1, 2021
K211696 — Disposable Surgical Face MaskAnhui Cleanpro Pharmpack Co., Ltd. Nov 30, 2021
K212664 — SherlockOpen Implants, LLC Nov 30, 2021
K202024 — ARROW Short Stem Humeral SystemFH Industrie Nov 30, 2021
K210117 — Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. Nov 30, 2021
K211668 — KardiaMobile CardAliveCor, Inc. Nov 30, 2021
K210836 — InstruSafe Instrument Protection SystemSummitt Medical, LLC Nov 30, 2021
K212814 — C2 CryoBalloon Ablation SystemPentax Of America, Inc. Nov 29, 2021
K213226 — RCT700Ray Co., Ltd. Nov 29, 2021
K210930 — ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)Johnson & Johnson Vision Care, Inc. Nov 29, 2021
K203748 — SeptiCyte RAPIDImmunexpress, Inc. Nov 29, 2021
K212762 — geko W-2Firstkind Limited Nov 29, 2021
K212237 — 3D-Cut3D-Side S.A. Nov 29, 2021
K211541 — MammoScreen 2.0Therapixel Nov 26, 2021
K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc. Nov 26, 2021
K202842 — Medical surgical maskHenan Huibo Medical Co., Ltd. Nov 26, 2021
K210782 — Tablo CartridgeOutset Medical, Inc. Nov 26, 2021
K212722 — Nitrile Examination GlovesWuhan Huirui Technology Co., Ltd. Nov 26, 2021
K212488 — Synthetic Nitrile Examination GlovesShandong Hongxin Chemicals Co., Ltd. Nov 26, 2021
K211139 — CUBE Air PurifierSamsung Electronics Co., Ltd. Nov 26, 2021
K211594 — Trevo Trak 21 MicrocatheterStryker Neurovascular Nov 26, 2021
K202537 — ALTMS Magnetic Stimulation Therapy SystemRemed Co., Ltd. Nov 26, 2021
K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc. Nov 24, 2021
K211894 — TrachealatorDisa Medinotec Nov 24, 2021
K210009 — Guiding CatheterCenterPoint Systems, LLC Nov 24, 2021
K211345 — C-30 Crown KitPerfect Fit Crowns, LLC Nov 24, 2021
K213455 — ControlRad Select Model ZControlrad, Inc. Nov 24, 2021
K212558 — MicroPen EVOEclipse Medcorp, LLC Nov 24, 2021
K211295 — Surgical Mask (sterile)Nanjing 3H Medical Products Co., Ltd. Nov 24, 2021
K211650 — The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. Nov 24, 2021
K212633 — Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, BlueString King Lacrosse, LLC Nov 24, 2021
K211744 — Non-Contact Infrared Thermometer, model HL710HHealth & Life Co., Ltd. Nov 24, 2021
K211463 — ReguloraMetame Health, Inc. Nov 24, 2021
K213214 — Xpert WristNewclip Technics Nov 24, 2021
K211983 — AMRA ProfilerAmra Medical AB Nov 24, 2021
K211169 — Bronchoscope SystemShanghai AnQing Medical Instrument Co., Ltd. Nov 24, 2021
K213454 — Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mmMedtronic Powered Surgical Solutions Nov 23, 2021
K211562 — Virtue RFShenB Co., Ltd. Nov 23, 2021
K211649 — PCEA Syringe SetBaxter Healthcare Corporation Nov 23, 2021
K203248 — Albumin BCG2Abbott Ireland Diagnostics Division Nov 23, 2021
← Previous Page 7 of 61 Next →