510(k) Clearances in 2022 — Page 36

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 36 of 65)
510(k) clearancesDetails
K220478 — NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated Jun 21, 2022
K220856 — Vial Adapter Ø13mmAvenir Performance Européenne Medical (Apem) Jun 21, 2022
K213665 — Syngo Carbon Space VA20ASiemens Healthcare GmbH Jun 21, 2022
K220482 — SherlockOpen Implants, LLC Jun 21, 2022
K211148 — CORE-TrocarIncore Co., Ltd. Jun 21, 2022
K203791 — Stainless TurbineNakanishi, Inc. Jun 21, 2022
K211979 — Lumenis Y&R Laser SystemLumenis, Inc. Jun 21, 2022
K213220 — Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. Jun 21, 2022
K220270 — Aspirex Thrombectomy SystemC.R. Bard, Inc. Jun 21, 2022
K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009Acutus Medical, Inc. Jun 21, 2022
K213228 — NeuroLine Disposable Cranial Perforator with Hudson endEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. Jun 20, 2022
K213197 — MyOnyx SystemThought Technology , Ltd. Jun 17, 2022
K221470 — Langston dual lumen catheterVascular Solutions, LLC Jun 17, 2022
K220523 — restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D Jun 17, 2022
K220813 — ART-PLANTherapanacea Jun 17, 2022
K221408 — ARIA Radiation Therapy Management (v16.1 MR3)Varian Medical Systems, Inc. Jun 17, 2022
K221217 — SPY LaparoscopeStryker Jun 17, 2022
K211099 — Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP Jun 17, 2022
K213037 — IDx-DR v2.3Digital Diagnostics, Inc. Jun 17, 2022
K221465 — Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. Jun 17, 2022
K221463 — ElucidVivo A.3Elucid Bioimaging, Inc. Jun 17, 2022
K220572 — Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. Jun 17, 2022
K212871 — Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) ElectrodeGalvanize Therapeutics, Inc. Jun 17, 2022
DEN210004 — Zuno Smart Sterilization ContainerZuno Medical, Inc. Jun 17, 2022
K221117 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jun 17, 2022
K220431 — Blue Nitrile Powder-Free Patient Examination Glove, Non-SterileOne Glove Industrial Sdn Bhd Jun 17, 2022
K213255 — CipherOx CRI TabletFlashback Technologies, Inc. Jun 17, 2022
K220210 — Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. Jun 17, 2022
K221226 — 1st Glove Blue Nitrile Examination Gloves Powder FreeKoove Iot Pvt. , Ltd. Jun 16, 2022
K201037 — FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation Jun 16, 2022
K212426 — Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd. Jun 16, 2022
K212870 — TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd. Jun 16, 2022
K212788 — Seer HomeSeer Medical Pty, Ltd. Jun 16, 2022
K201348 — DePuy 3D Additive TriFlange Acetabular CupDepuy International, Ltd. Jun 16, 2022
K221186 — TC GlovesThanh Cong Pharmaceutical And Trading Company Limited Jun 16, 2022
K220878 — Straumann TLX Variobase CInstitut Straumann AG Jun 16, 2022
K220469 — Disposable Vinyl Examination GloveChifeng Huawei Medical Science&Technology Co., Ltd. Jun 16, 2022
K221345 — Wireless Digital Flat Panel DetectorIray Technology Taicang , Ltd. Jun 16, 2022
K220299 — Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. Jun 16, 2022
K203624 — Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd. Jun 16, 2022
K213504 — Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation Jun 16, 2022
K220399 — WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image SystemOTU Medical, Inc. Jun 16, 2022
K220440 — Dentis s-Clean Abutment MiniDentis Co., Ltd. Jun 16, 2022
K221448 — ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)Varian Medical Systems, Inc. Jun 15, 2022
K220614 — MEDOJECT fine Pen NeedlesChirana T. Injecta Jun 15, 2022
K213088 — ZQuiet AdvanceSleeping Well, LLC Jun 15, 2022
K220106 — QardioArm 2Qardio, Inc. Jun 15, 2022
K220804 — Dia-X Bond UniversalDiaDent Group International Jun 15, 2022
K213684 — SurgiCase ViewerMaterialise NV Jun 15, 2022
K213626 — VITROS AFPOrtho Clinical Diagnostics Jun 15, 2022
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