510(k) Clearances in 2022 — Page 26

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 26 of 65)
510(k) clearancesDetails
K220292 — Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. Aug 19, 2022
K212525 — Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesAdvcare Medical Aug 19, 2022
K222130 — 1688 4K Camera System with Advanced Imaging ModalityStryker Aug 19, 2022
K221023 — Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5Spinal Simplicity, LLC Aug 19, 2022
K220193 — BD MAX Enteric Parasite PanelBecton, Dickinson And Company Aug 19, 2022
K221403 — Cortera Spinal Fixation SystemSurgalign Spine Technologies Aug 19, 2022
K220016 — Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG Aug 19, 2022
K221848 — prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC Aug 19, 2022
K222194 — Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc. Aug 19, 2022
K203078 — CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AWHuizhou Tianchang Industrial Co., Ltd. Aug 19, 2022
K221824 — OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315Cipher Surgical Limited Aug 19, 2022
K213520 — AXIR-CXRadisen Co., Ltd. Aug 19, 2022
K213758 — Lexa PLUS RIS-311W&H Sterilization S.R.L. Aug 19, 2022
K212856 — iClean Viral Transport System (VTM-RT kit)Huachenyang (Shenzhen) Technology Co. , Ltd. Aug 18, 2022
K221353 — Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VSQura S.R.L Aug 18, 2022
K220647 — GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)Vascular Solutions, LLC Aug 18, 2022
K221213 — EnSite X EP SystemAbbott Aug 18, 2022
K220959 — OR3O Dual Mobility SystemSmith & Nephew, Inc. Aug 18, 2022
K212518 — Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. Aug 18, 2022
K213390 — Benchmark BMX96 Access SystemPenumbra, Inc. Aug 18, 2022
K221520 — Miro3D Wound MatrixReprise Biomedical, Inc. Aug 18, 2022
K210797 — Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd. Aug 18, 2022
K222272 — truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184STERIS Corporation Aug 18, 2022
K212905 — Sotair DeviceSafe Bvm Corporation Aug 18, 2022
K210678 — implaFit® hip stemsImplantcast GmbH Aug 17, 2022
K220387 — Disposable Blood LancetsSuzhou Kyuan Medical Apparatus Co., Ltd. Aug 17, 2022
K220897 — Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie Aug 17, 2022
K221838 — Surgical Face Mask (HNFM0103)Shanghai Hua EN Industrial Co, Ltd. Aug 17, 2022
K221112 — CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)Biosense Webster, Inc. Aug 17, 2022
K220452 — Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerMaterialise NV Aug 17, 2022
K221844 — TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd. Aug 17, 2022
K212033 — Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needleShandong Zhushi Pharmaceutical Group Co., Ltd. Aug 17, 2022
K220530 — Tetragraph Neuromuscular Transmission MonitorSenzime AB Aug 17, 2022
K212273 — Cross Protection ResQ300 Plus Surgical Face MaskCross Protection (M) Sdn Bhd Aug 17, 2022
K220903 — WebCephAssemblecircle Corp. Aug 17, 2022
K222169 — FairFix Adjustable Button SystemMedacta International S.A. Aug 16, 2022
K220433 — syngo Application Software (VE21)Siemens Medical Solution USA, Inc. Aug 16, 2022
K220329 — G-CAMGraphenano Dental S.L. Aug 16, 2022
K221190 — ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Aug 16, 2022
K221852 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc. Aug 16, 2022
K213026 — Clear AlignerShenzhen Meiming Dentistry Technology Co., Ltd. Aug 16, 2022
K213426 — HemosIL ReadiPlasTinInstrumentation Laboratory CO Aug 16, 2022
K213937 — Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 SolutionO&M Halyard, Inc. Aug 16, 2022
K212385 — YUWELL Finger Pulse OximeterJiangsu Yuyue Medical Equipment & Supply Co., Ltd. Aug 16, 2022
K213845 — HeRO GraftMerit Medical Systems, Inc. Aug 15, 2022
K212790 — XLase PlusBiotec Italia, Srl Aug 15, 2022
K221302 — Recon Steerable SheathSerpex Medical, Inc. Aug 15, 2022
K213527 — FORUMCarl Zeiss Meditec, AG Aug 15, 2022
K220163 — Her-2, ER, PR IHControlsBoston Cell Standards, Inc. Aug 15, 2022
K214095 — da Vinci X/Xi (IS4200/IS4000) 8mm Reusable InstrumentsIntuitive Surgical, Inc. Aug 15, 2022
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