510(k) Clearances in 2022 — Page 33

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 33 of 65)
510(k) clearancesDetails
K213873 — SkyWalker Total Knee SystemMicroport Navibot International, LLC Jul 7, 2022
K220534 — Wet Essential95 Personal LubricantTrigg Laboratories, Inc. Jul 7, 2022
K221246 — IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd. Jul 7, 2022
K212472 — AgeJetTriworks Group Srl Jul 7, 2022
K221654 — medi pneumatic compression system (pcs)-genius (Model 652)Medi USA, LP Jul 7, 2022
K221679 — IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd. Jul 7, 2022
K220475 — Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)Tianjin Huahong Technology Co., Ltd. Jul 6, 2022
K213007 — Cerebra Sleep SystemCerebra Medical , Ltd. Jul 6, 2022
K212819 — Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation Jul 6, 2022
K220024 — ChoiceSpine Navigation SystemChoice Spine, LLC Jul 6, 2022
K212815 — My3D® Personalized Pelvic ReconstructionOnkos Surgical Jul 6, 2022
K210069 — Minuteful - kidney testHealthy.Io, Ltd. Jul 6, 2022
K212822 — Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation Jul 6, 2022
K221028 — SURGIVISIO DeviceEcential Robotics Jul 6, 2022
K214038 — Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. Jul 6, 2022
K212820 — Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation Jul 6, 2022
K221426 — Functional MR V1.0Olea Medical S.A.S. Jul 6, 2022
K221173 — Surgical Mask (Model: 0868F, 0866F)Jiangxi Sanhao Medical Instruments Co.,Ltd Jul 6, 2022
K221033 — UniPrime A, UniPrime E, UniPrime E/CS&C Polymer Silicon- Und Composite Spezialitäten GmbH Jul 6, 2022
K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. Jul 6, 2022
K220827 — Electric WheelchairFoshan Dahao Medical Technology Co., Ltd. Jul 5, 2022
K213360 — SleepCheckRxResapp Health Jul 5, 2022
K220743 — CediTECVoco GmbH Jul 5, 2022
K221019 — Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) Jul 5, 2022
K221337 — Materialise TKA Guide SystemMaterialise NV Jul 5, 2022
K213521 — Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. Jul 1, 2022
K221036 — Astroglide WarmingBiofilm, Inc. Jul 1, 2022
K220317 — PuraPly Micronized Wound Matrix (PuraPly MZ)Organogenesis, Inc. Jul 1, 2022
K220660 — Prevena Restor Adapti-Form Dressing3M Healthcare Business Group Jul 1, 2022
K221395 — Footmotion Plating SystemNewclip Technics Jul 1, 2022
K220500 — Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbH Jul 1, 2022
K213385 — GEMObsidio, Inc. Jul 1, 2022
K211150 — Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd. Jul 1, 2022
K221025 — i_ Field 1.5T Superconducting Magnetic Resonance Imaging SystemMri Division,Beijing Wandong Medical Technology Co., Ltd. Jul 1, 2022
K221176 — Insulin Pen NeedleTianjin Huahong Technology Co., Ltd. Jul 1, 2022
K211085 — BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson And Company Jul 1, 2022
K203134 — Hanger Cranial Band 3DSymbion Logistics, LLC Jul 1, 2022
K214050 — ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis) Jul 1, 2022
K220248 — Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. Jul 1, 2022
K220784 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Jul 1, 2022
K213315 — CROSSLEAD Peripheral Guide WireAsahi Intecc Co., Ltd. Jul 1, 2022
K213871 — Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC Jul 1, 2022
K220298 — CerroZone MobileCerrozone Jul 1, 2022
K220171 — NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc. Jul 1, 2022
K221909 — J-TempUltradent Products, Inc. Jul 1, 2022
K213488 — Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd. Jul 1, 2022
K211176 — Smith & Nephew Hip SystemsSmith & Nephew, Inc. Jul 1, 2022
K221625 — 2-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation Jul 1, 2022
K221026 — Power WheelchairZhejiang Innuovo Rehabilitation Devices Co.,Ltd Jul 1, 2022
K213232 — NovaCore Semi-Automatic Biopsy InstrumentArgon Medical Devices Jul 1, 2022
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