510(k) Clearances in 2022 — Page 5

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 5 of 65)
510(k) clearancesDetails
K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. Dec 9, 2022
K222753 — SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation Dec 9, 2022
K222086 — Inogen Rove 4 Portable Oxygen ConcentratorInogen Dec 9, 2022
K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf) Dec 9, 2022
K222117 — Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC Dec 9, 2022
K223402 — HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO Dec 9, 2022
K220826 — LED Curing LightFoshan Coxo Medical Instrument Co., Ltd. Dec 8, 2022
K220667 — Sleeved ICHollister Incorporated Dec 8, 2022
K221444 — LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V. Dec 8, 2022
K221182 — Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty) , Ltd. Dec 8, 2022
K222750 — Yomi Robotic SystemNeocis, Inc. Dec 8, 2022
K221862 — YY-A02-B Overlapped Compression TherapyHuizhou Xinyi Technology Co., Ltd. Dec 8, 2022
K213210 — Oxygen Concentrator, Model JAY-5AWLongfian Scitech Co., Ltd. Dec 8, 2022
K223487 — InkSpace Imaging Body ArrayInkspace Imaging, Inc. Dec 8, 2022
K222471 — IRRAflow Active Fluid Exchange System (AFES)Irras USA Dec 8, 2022
K222038 — CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemAbbott (Formerly Thoratec Corporation) Dec 8, 2022
K223112 — MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. Dec 8, 2022
K222837 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc. Dec 8, 2022
K211800 — Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd. Dec 8, 2022
K223239 — 8ch Wrist CoilShenzhen RF Tech Co., Ltd. Dec 8, 2022
K212567 — PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd. Dec 7, 2022
K220772 — HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. Dec 7, 2022
K223045 — 3-Ply Disposable Medical MaskWealth Lead Industrial Limited Dec 7, 2022
K223281 — Disposable Nitrile Examination GloveAnhui Kindguard Medical Supplies Technology Co., Ltd. Dec 7, 2022
K220843 — OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC Dec 7, 2022
K223410 — Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. Dec 7, 2022
K223077 — ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company Dec 7, 2022
K223394 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)Visionary Optics, LLC Dec 7, 2022
K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA Dec 7, 2022
K222441 — Ultrasound System 2300Bk Medical Aps Dec 7, 2022
K221842 — Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics Dec 7, 2022
K213919 — Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. Dec 7, 2022
K221626 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl CitrateJr Engineering & Medical Technologies (M) Sdn. Bhd. Dec 7, 2022
K222385 — Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd. Dec 6, 2022
K223386 — Optima Coil SystemBalt USA, LLC Dec 6, 2022
K222320 — MedDreamSoftneta Uab Dec 6, 2022
K222575 — HurriChem Device KitThermasolutions, LLC Dec 6, 2022
K222626 — Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. Dec 6, 2022
K223409 — Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. Dec 6, 2022
K223632 — Premier's MultiMatch Universal Chameleon Restorative CompositePremier Dental Products Company Dec 6, 2022
K222706 — iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. Dec 6, 2022
K221021 — Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A Dec 6, 2022
K222219 — R2 Studio Q/RCT820Megagen Implant Co., Ltd. Dec 6, 2022
K223247 — Swoop Portable MR Imaging SystemHyperfine, Inc. Dec 6, 2022
K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, Incorporated Dec 6, 2022
K213169 — BPAP SystemBMC Medical Co., Ltd. Dec 5, 2022
K222681 — Altaviz Needle KitAltaviz, LLC Dec 5, 2022
K222137 — OK Plus IndicatorPropper Manufacturing Co., Inc. Dec 5, 2022
K222669 — Cryopush Cold Compression DeviceChengdu Cryo-Push Medical Technology Co.,Ltd Dec 5, 2022
K221806 — TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. Dec 5, 2022
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