510(k) Clearances in 2022 — Page 13

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 13 of 65)
510(k) clearancesDetails
K221489 — Artemis Proximal Femoral Nail SystemGlw, Inc. Oct 27, 2022
K222282 — HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company Oct 27, 2022
K220949 — Architect CMV IgGAbbott Laboratories Oct 27, 2022
K222505 — CurvaFix IM SystemCurvafix, Inc. Oct 27, 2022
K220332 — uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd. Oct 27, 2022
K222032 — NEUROMARK SystemNeurent Medical Oct 26, 2022
K220132 — FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc. Oct 26, 2022
K222631 — VASSALLO GT EXTFilmecc Co., Ltd. Oct 26, 2022
K223058 — EzRay Air 2 Wall (Model: VEX-S350W)VATECH Co., Ltd. Oct 26, 2022
K222269 — DESS Dental Smart SolutionsTerrats Medical SL Oct 26, 2022
K222366 — EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. Oct 26, 2022
K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions AB Oct 26, 2022
K221885 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. Oct 26, 2022
K220823 — Preat AbutmentsPreat Corporation Oct 26, 2022
K223065 — Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc. Oct 26, 2022
K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)Hebei Titans Hongsen Medical Technology Co., Ltd. Oct 26, 2022
K223235 — Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)Pt. Sintong Unigolden Glove Oct 26, 2022
K221218 — Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. Oct 26, 2022
K223060 — DigiX FDXAllengers Medical Systems Limited Oct 26, 2022
K222807 — TEMA Elbow system - Line extensionLima Corporate S.P.A. Oct 26, 2022
K222498 — Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)Humanwell Healthcare Group Medical Supplies Co., Ltd. Oct 26, 2022
K213690 — Eclipse Blood Collection SetEclipse Medcorp, LLC Oct 26, 2022
K222281 — Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. Oct 26, 2022
K222470 — 3Dicom MDSingular Health Pty, Ltd. Oct 25, 2022
K222070 — EndoNautTherenva Sas Oct 25, 2022
K222968 — Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Oct 25, 2022
K222303 — Unistik® ProOwen Mumford, Ltd. Oct 25, 2022
K222365 — Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. Oct 25, 2022
K222415 — Rexious Spinal Fixation SystemDio Medical Corporation Oct 25, 2022
K221169 — JR MEDIC Nitrile Examination Gloves Powder Free- BlackJr Engineering & Medical Technologies (M) Sdn. Bhd. Oct 25, 2022
K212649 — Disposable Surgical Face MaskLyncmed Medical Technology (Beijing) Co., Ltd. Oct 25, 2022
K220565 — Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc. Oct 25, 2022
K221545 — MectaLIF Anterior ExtensionMedacta International S.A. Oct 24, 2022
K220190 — The GIRO Growth Modulation SystemPega Medical, Inc. Oct 24, 2022
K221563 — Neurosteer EEG RecorderNeurosteer, Inc. Oct 24, 2022
K222127 — Soft Palate ElevatorThe Tmj Clinic PC Oct 24, 2022
K221783 — SafetiCET Safety LancetNsp Tech Pte, Ltd. Oct 24, 2022
K212493 — KODEX – EPD™ System 1.5.0Philips Medical Systems Nederland, B.V. (Pmsn) Oct 24, 2022
K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. Oct 22, 2022
K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantWrp Asia Pacific Sdn. Bhd. Oct 22, 2022
K222199 — Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC Oct 21, 2022
K222201 — Biological Feedback and Stimulation SystemMedlander Medical Technology, Inc. Oct 21, 2022
K223042 — Viz LVO ContaCTViz. Ai, Inc. Oct 21, 2022
K222349 — JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)Jr Engineering & Medical Technologies (M) Sdn. Bhd. Oct 21, 2022
K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo GownMedtecs (Taiwan) Corp. Oct 21, 2022
K212391 — MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. Oct 21, 2022
K221443 — PureLift Pro PlusXtreem Pulse, LLC Oct 21, 2022
K221462 — DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC Oct 21, 2022
K221958 — Flex-MIEmsi, Inc. Oct 21, 2022
K221022 — NextDent Ortho FlexVertex-Dental B.V. Oct 21, 2022
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