510(k) Clearances — Page 171
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230969 — Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222780 — LILY Extension Tube and Needleless Connector | Lily Medical Corporation Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231508 — Power Wheelchair, W5521 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233596 — VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231366 — Neuronaute Plus | Bioserenity Sas Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231617 — MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231920 — Longeviti ClearFit OTS Cranial Implant | Longeviti Neuro Solutions, LLC Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233408 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233366 — SYMPHONY OCT System | Medos International SARL Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232442 — Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co., Ltd. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231277 — TissueStat | Durastat, LLC Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223754 — BraveCX | Bering, Ltd. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230828 — Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231911 — Glenoid Reconstruction System Full Wedge Baseplate | Medacta International S.A. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231150 — Cardio P1 | Bionet Co., Ltd. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231804 — PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231752 — ARK Hydrocodone Assay | Ark Diagnostics, Inc. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231724 — Flush Syringe (Prefilled 0.9% normal saline solution) | Spm Medicare Pvt. , Ltd. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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-C1U | Qura S.R.L Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232152 — NerivioInfinity | Theranica Bioelectronics , Ltd. Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223739 — VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231765 — Contour ProtégéAI | Mim Software, Inc. Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220091 — Dream Sock | Owlet Babycare, Inc. Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230534 — BriefCase-Quantification | Aidoc Medical , Ltd. Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232886 — INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Healthium Medtech Limited Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231798 — da Vinci SP Surgical System | Intuitive Surgical, Inc. Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230400 — Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232866 — Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) | Jiangsu Channel Medical Device Co., Ltd. Tue Nov 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231966 — LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics Tue Nov 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232292 — Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. Tue Nov 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231155 — Biodegradable Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. Tue Nov 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233420 — Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular Tue Nov 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231989 — LOGIQ E10s, LOGIQ Fortis | Ge Medical Systems Ultrasound and Primary Care Diagnostic, Tue Nov 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232476 — Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. Tue Nov 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231470 — Lunit INSIGHT DBT | Lunit, Inc. Mon Nov 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232857 — KARL STORZ ICG Imaging System | Karl Storz SE & CO. KG Mon Nov 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231865 — Mouth Guard (ATG0603R) | Reazeal Corp Mon Nov 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220090 — EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) | Stemcell Technologies Canada, Inc. Mon Nov 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231519 — Revital Cady | Revital Healthcare (Epz) Limited Mon Nov 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231316 — Aptima Trichomonas vaginalis Assay | Hologic, Inc. Mon Nov 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230475 — Medical Video Endoscope System | Huger Medical Instrument Co., Ltd. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230481 — Evenflo Premium Double Electric Breast Pump (Model 4018) | Evenflo Feeding, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232251 — APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | Medartis AG Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231955 — aprevo® Digital Segmentation | Carlsmed, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232742 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230078 — TRAX® CR Total Knee System | Amplitude Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233428 — Easycess Aspiration Pump | Guangzhou Easycess Medical Co.,Ltd Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231586 — Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |