510(k) Clearances in 2022 — Page 38

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 38 of 65)
510(k) clearancesDetails
K221371 — Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. Jun 8, 2022
K213717 — AIR Recon DLGe Medical Systems,Llc (Ge Healthcare) Jun 8, 2022
K213173 — TrabEx ProMicrosurgical Technologies, Inc. Jun 8, 2022
K213862 — HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd. Jun 8, 2022
K212933 — INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC Jun 8, 2022
K221389 — FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A. Jun 8, 2022
K213882 — EarliPoint SystemEarlitec Diagnostics, Inc. Jun 8, 2022
K213185 — ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kitsColoplast Corp. Jun 8, 2022
K213087 — Natural Rubber Latex Ultrasound Transducer Probe CoversGlobal Protection Corp. Jun 7, 2022
K221438 — WHILL Model FWhill, Inc. Jun 7, 2022
K221335 — D²RS and D²RS 9090Stephanix Jun 7, 2022
K203579 — Infinity Gateway SuiteDraeger Medical Systems, Inc. Jun 7, 2022
K210804 — Adhese Universal DC, Cention PrimerIvoclar Vivadent, AG Jun 7, 2022
K220455 — Lap-Band System Calibration TubeReshape Lifesciences Jun 7, 2022
K220693 — Zoupure Nitrile Powder Free Examination gloveThai Rayong Product Glove Zoupure Co., Ltd. Jun 7, 2022
K213117 — FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. Jun 7, 2022
K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid Jun 7, 2022
K221231 — Drug Relief v1Dyansys, Inc. Jun 6, 2022
K220358 — Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound And Primary Care Diagnostics Jun 6, 2022
K213448 — Powder Free Nitrile GlovesSt Future International Limited Jun 6, 2022
K211207 — Diacare 7000Globus Sport And Health Technologies, LLC Jun 6, 2022
K212450 — Keos Anterior Cervical Interbody Fusion Device SystemKeos Jun 6, 2022
K220612 — PrimeLOC Attachment SystemInnovative Product Brands, Inc. Jun 6, 2022
K220947 — Arthrex Knotless AC Repair DevicesArthrex, Inc. Jun 6, 2022
K213222 — Disposable Polypectomy SnareBeijing Zksk Technology Co., Ltd. Jun 6, 2022
K213223 — Multi-Band LigatorBeijing Zksk Technology Co., Ltd. Jun 6, 2022
K221222 — Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd. Jun 6, 2022
K221366 — Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc. Jun 6, 2022
K213846 — Q2 Blood Administration SetsQuest Medical, Inc. Jun 5, 2022
K220321 — Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) TigrisHologic, Inc. Jun 3, 2022
K214063 — Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy NeedleGuangzhou Shengwei Medical Devices Co., Ltd. Jun 3, 2022
K210741 — KLS Martin Neuro RongeursKLS-Martin L.P. Jun 3, 2022
K213931 — VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc. Jun 3, 2022
K220672 — Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test ClaimRiverstone Resources Sdn Bhd Jun 3, 2022
K214089 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation Jun 3, 2022
K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. Jun 3, 2022
K213924 — Gastric Alimetry SystemAlimetry , Ltd. Jun 3, 2022
K220665 — Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-SterileExcellent Medical Technology Group Co., Ltd. Jun 3, 2022
K213977 — TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc. Jun 3, 2022
K213971 — Atrial Fibrillation History FeatureApple, Inc. Jun 3, 2022
K221314 — BriefCaseAidoc Medical , Ltd. Jun 3, 2022
K220633 — MICROLET NEXT lancing device, MICROLET LancetAscensia Diabetes Care U.S., Inc. Jun 3, 2022
K210084 — SILKROHironic Co., Ltd. Jun 3, 2022
K211567 — BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG Jun 3, 2022
K220205 — 3D Anatomic ModelsRicoh USA, Inc. Jun 3, 2022
K213332 — Multifrax Laser SystemParadigm Medical Corporation Jun 3, 2022
K210371 — Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science And Technology Co., Ltd. Jun 3, 2022
K221061 — 21HQ613DLg Electronics.Inc Jun 3, 2022
K220761 — CIRCUL8 Connect DVT Prevention DeviceOrtho8, Inc. Jun 3, 2022
K220652 — Knee 3Brainlab AG Jun 3, 2022
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