510(k) Clearances in 2019 — Page 5

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 5 of 59)
510(k) clearancesDetails
K191793 — Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating SystemNebula Surgical Private Limited Dec 9, 2019
K181900 — Dental high speed handpiece, Dental low speed handpieceFoshan Cicada Dental Instrument Co, Ltd. Dec 9, 2019
K190968 — CEDIA Benzodiazepine AssayMicrogenics Corporation Dec 9, 2019
K191054 — Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd. Dec 9, 2019
K191700 — EyeStatBlinktbi, Inc. Dec 9, 2019
K192522 — TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3I, LLC Dec 9, 2019
K192439 — JETi Peripheral Thrombectomy SystemWalk Vascular, LLC Dec 9, 2019
K192885 — C.T.M. Mobility Scooter HS-268Chien TI Enterprise Co., Ltd. Dec 9, 2019
K190273 — T3 Platform softwareEtiometry, Inc. Dec 8, 2019
K192279 — PhantomMSK TraumaOrthoGrid Systems, Inc. Dec 7, 2019
K190382 — Intraocular Pressure Tonometer EASYTONCompany Elamed Dec 6, 2019
K192324 — Sheridan Spiral-Flex Endotracheal TubesTeleflexmedical, Inc. Dec 6, 2019
K193030 — Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH Dec 6, 2019
K190656 — Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc. Dec 6, 2019
K192773 — ALLIVENu Eyne Co., Ltd. Dec 6, 2019
K191239 — Smart Peak Flow MeterGuangzhou Homesun Medical Technology Co., Ltd. Dec 6, 2019
K192443 — Dextile Anatomical MeshSofradim Production Dec 6, 2019
K190552 — JJ Implant SystemJj Implants Dec 6, 2019
K190612 — EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. Dec 6, 2019
K183052 — ID-Cap SystemEtectrx, Inc. Dec 6, 2019
K192521 — Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd. Dec 6, 2019
K191861 — Aurora Surgiscope SystemRebound Therapeutics Dec 6, 2019
K191279 — Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd. Dec 6, 2019
K182758 — MCI - CMF SystemMci Medical Concept Innovation, Inc. Dec 5, 2019
K192224 — BTL-899Btl Dec 5, 2019
K193028 — MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. Dec 5, 2019
K191864 — 21HK512DLg Electronics.Inc Dec 5, 2019
K191804 — TOMi ScopePhotonicare, Inc. Dec 5, 2019
K190660 — G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked PolyethyleneZimmer, Inc. Dec 5, 2019
DEN190016 — cobas vivoDx MRSARoche Molecular Systems, Inc. Dec 5, 2019
K191962 — Vitra 2Quantel Medical Dec 5, 2019
K191250 — Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd. Dec 5, 2019
K191191 — Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A. Dec 5, 2019
K191996 — BC Reflex Uni Knee SystemBodycad Laboratories, Inc. Dec 5, 2019
K191760 — PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited Dec 5, 2019
K192482 — Elekta UnityElekta Limited Dec 5, 2019
K192766 — Digital Intraoral Imaging Plate SystemFsusen Technology Co., Ltd. Dec 5, 2019
K193020 — VenaPro Vascular Therapy SystemInnovamed Health, LLC Dec 4, 2019
K191379 — RELiZORBAlcresta Therapeutics, Inc. Dec 4, 2019
K193068 — AIROS 8 Sequential Compression DeviceAiros Medical, Inc. Dec 4, 2019
K191759 — Medline Quick Switch Valve with ENFit ConnectorMedline Industries, Inc. Dec 4, 2019
K193069 — AIROS 6 Sequential Compression DeviceAiros Medical, Inc. Dec 4, 2019
K191371 — MolecuLight i:XMolecuLight, Inc. Dec 4, 2019
K192348 — SICAT Implant V2.0Sicat GmbH & Co. KG Dec 4, 2019
K192430 — Epic 980Biolase, Inc. Dec 4, 2019
K192335 — TRACKER Kyphoplasty SystemGS Medical Co., Ltd. Dec 4, 2019
K193083 — M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A. Dec 3, 2019
K192132 — SeaSpine Beachside SystemSeaSpine Orthopedics Corporation Dec 3, 2019
K192473 — Exsomed Wrist Plating SystemExsomed Corporation Dec 3, 2019
K193107 — TriSalus Infusion SystemTrisalus Life Sciences Dec 3, 2019
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