510(k) Clearances — Page 186

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 186 of 3,525)
ClearancesDetails
K231521 — Broncho Videoscope SystemScivita Medical Technology Co., Ltd. Nov 14, 2023
K232050 — saremco print BRIDGETECSaremco Dental AG Nov 14, 2023
K232845 — IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd. Nov 14, 2023
K230878 — QScout Lab; QScout RLDAd Astra Diagnostics, Inc. Nov 14, 2023
K231554 — UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd. Nov 14, 2023
K233468 — Iconix AnchorRiverpoint Medical Nov 14, 2023
K232488 — Accu-Chek Safe-T-Pro Plus Lancing DeviceRoche Diabetes Care, Inc. Nov 13, 2023
K232241 — Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)Betters(Suzhou) Medical Co., Ltd. Nov 13, 2023
K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC Nov 13, 2023
K232240 — Microwave Ablation System (BD-GT)Betters(Suzhou) Medical Co., Ltd. Nov 13, 2023
K232257 — Clarius Bladder AIClarius Mobile Health Corp. Nov 13, 2023
K232509 — Accu-Chek Safe-T-Pro Uno Lancing DeviceRoche Diabetes Care, Inc. Nov 13, 2023
K231937 — Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. Nov 13, 2023
K231118 — Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd. Nov 13, 2023
K232083 — BriefCase-QuantificationAidoc Medical , Ltd. Nov 13, 2023
K230849 — ELLAVI UBTSinapi Biomedical (Pty) , Ltd. Nov 13, 2023
K231564 — Skin and Wound CleanserWinner Medical Co., Ltd. Nov 10, 2023
K231920 — Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC Nov 9, 2023
K233408 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV Nov 9, 2023
K230969 — Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. Nov 9, 2023
K231366 — Neuronaute PlusBioserenity Sas Nov 9, 2023
K233596 — VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG Nov 9, 2023
K232442 — Disposable Endoscope Injection NeedlesZhejiang Soudon Medical Technology Co., Ltd. Nov 9, 2023
K222780 — LILY Extension Tube and Needleless ConnectorLily Medical Corporation Nov 9, 2023
K231508 — Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Nov 9, 2023
K231617 — MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc. Nov 9, 2023
K233366 — SYMPHONY OCT SystemMedos International SARL Nov 9, 2023
K231277 — TissueStatDurastat, LLC Nov 9, 2023
K223754 — BraveCXBering, Ltd. Nov 9, 2023
K230828 — Flowflex COVID-19 Antigen Home TestACON Laboratories, Inc. Nov 9, 2023
K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V. Nov 9, 2023
K231911 — Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. Nov 9, 2023
K231150 — Cardio P1Bionet Co., Ltd. Nov 9, 2023
K231804 — PRIME-XV FreezIS DMSO-Free MDFujifilm Irvine Scientific Nov 9, 2023
K231752 — ARK Hydrocodone AssayArk Diagnostics, Inc. Nov 9, 2023
K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd. Nov 9, 2023
K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. Nov 9, 2023
K231798 — da Vinci SP Surgical SystemIntuitive Surgical, Inc. Nov 8, 2023
K223739 — VS Tabletop TonometerMedimaging Integrated Solution, Inc. Nov 8, 2023
K232152 — NerivioInfinityTheranica Bioelectronics , Ltd. Nov 8, 2023
DEN220091 — Dream SockOwlet Babycare, Inc. Nov 8, 2023
K231773 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1UQura S.R.L Nov 8, 2023
K231765 — Contour ProtégéAIMim Software, Inc. Nov 8, 2023
K230534 — BriefCase-QuantificationAidoc Medical , Ltd. Nov 8, 2023
K232886 — INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited Nov 8, 2023
K230400 — Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc. Nov 8, 2023
K232866 — Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)Jiangsu Channel Medical Device Co., Ltd. Nov 7, 2023
K231966 — LOGIQ E10GE Medical Systems Ultrasound And Primary Care Diagnostics Nov 7, 2023
K232292 — Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. Nov 7, 2023
K231155 — Biodegradable Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. Nov 7, 2023
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