510(k) Clearances in 2021 — Page 27

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 27 of 61)
510(k) clearancesDetails
K203305 — Tiger Reusable Sharps ContainerInternational Marketing Specialists, Inc. Aug 6, 2021
K211725 — Senographe PristinaGE Healthcare Aug 6, 2021
K211764 — Vereos PET/CTPhilips Medical Systems Nederland B.V. Aug 6, 2021
K210725 — Nitrile Patient Examination GlovePingan Medical Products Co., Ltd. Aug 6, 2021
K211783 — TriMed Threaded Intramedullary Nail SystemTriMed, Inc. Aug 6, 2021
K211435 — PAO Cortical ScrewMedacta International S.A. Aug 6, 2021
K203136 — Diazyme PLAC® Test for Lp-PLA2 ActivityDiazyme Laboratories, Inc. Aug 6, 2021
K210541 — ulrichINJECT CT motionUlrich GmbH & Co. KG Aug 6, 2021
K211784 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc. Aug 6, 2021
K210320 — ClearCorrect SystemClearcorrect, LLC Aug 6, 2021
K201089 — ARK Lacosamide AssayArk Diagnostics, Inc. Aug 5, 2021
K211075 — Disposable Medical Nitrile Examination Gloves (Non-Sterile)Jiangsu Cherish Medical Technology Co., Ltd. Aug 5, 2021
K202969 — Biomet Microfixation OmniMax MMF SystemBiomet Microfixation Aug 5, 2021
K210680 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Aug 5, 2021
K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc. Aug 5, 2021
K211434 — Nitrile Patient Examination GlovesZhangjiagang Huayuan Protective Equipment Co., Ltd. Aug 5, 2021
K211608 — Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)Jiangsu Cureguard Glove Co., Ltd. Aug 5, 2021
K211893 — SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc. Aug 5, 2021
K203362 — TRACOE varioTracoe Medical GmbH Aug 5, 2021
K211657 — EMPHASYS Femoral StemsDepuy Ireland UC Aug 5, 2021
K203727 — Harmony Latex Dam, Harmony Non-Latex DamPamco Distributing, Inc. Aug 5, 2021
K211388 — Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc. Aug 5, 2021
K203006 — R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. Aug 5, 2021
K202621 — NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc. Aug 5, 2021
K211553 — Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc. Aug 4, 2021
K210643 — Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. Aug 4, 2021
K203464 — DESS Dental Smart SolutionsTerrats Medical SL Aug 4, 2021
K211049 — Tigon Medical Button SystemTigon Medical Aug 4, 2021
K211838 — Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation Aug 4, 2021
K203246 — Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)Atlas Link Technology Co., Ltd. Aug 4, 2021
K210913 — V12 PROSlk Medical GmbH Aug 4, 2021
K212056 — Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Aug 4, 2021
K211502 — Alpha Vent PEEK Suture AnchorStryker Endoscopy Aug 4, 2021
K211714 — Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)Hengchang (Dongying) Medical Technology Co., Ltd. Aug 4, 2021
K211068 — PrevisEA DeviceEntac Medical, Inc. Aug 4, 2021
K211758 — Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)Hartalega NGC Sdn. Bhd. Aug 3, 2021
K211026 — Minitube Dentasleeve Protective Barrier SleevesMinitube AB Aug 3, 2021
K211290 — Cannulated Fasteners and NutsOsteoCentric Technologies Aug 3, 2021
K201246 — PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)Qualimed USA, LLC Aug 3, 2021
K211897 — Surgical Face MaskZhejiang Hongyu Medicali Commodity Co., Ltd. Aug 3, 2021
K211806 — Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven CatheterVenclose, Inc. Aug 3, 2021
K212144 — Remex KA6Remedi Co., Ltd. Aug 3, 2021
K210651 — Resection Electrodes with HF cableOlympus Winter & Ibe GmbH Aug 3, 2021
K210724 — ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsCareplus (M) Sdn Bhd Aug 3, 2021
K210339 — Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. Aug 2, 2021
K203538 — SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)Medline Industries, Inc. Aug 2, 2021
K200986 — OPTI® B-Lac CassetteOpti Medical Systems, Inc. Aug 2, 2021
K203174 — Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd. Aug 2, 2021
K212106 — RelivionNeurolief , Ltd. Aug 2, 2021
K212175 — DynaCADInvivo Corporation Aug 2, 2021
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