510(k) Clearances — Page 152
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233526 — Medline Open-back Level 3 Protective Gown | Medline Industries, LP Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240597 — TERA HARZ CLEAR | Graphy, Inc. Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231210 — DGA Abutment | Modern Dental Laboratory (Dg) Co., Ltd. Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233859 — BASIS FLOW II | YAMAHACHI DENTAL MFG., Co. Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240459 — Cerament Bone Void Filler | Bonesupport AB Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240090 — Argo Knotless GENESYS Anchor | Conmed Corporation Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231260 — HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology Co., Ltd. Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234070 — Stelo Glucose Biosensor System | Dexcom, Inc. Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240404 — NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | Novabone Products, LLC Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233877 — XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | Magic Mobility Mon Mar 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233738 — Overjet Caries Assist-Pediatric | Overjet, Inc. Mon Mar 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240453 — ReBOSSIS | Orthorebirth Co., Ltd. Mon Mar 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231288 — Vyvo | Vyvo Technology Corp.(Vt) Mon Mar 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230047 — Medical Diode Laser Systems | Gigaalaser Company , Ltd. Mon Mar 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240023 — Probe Covers (YF-001, YF-002) | Shenzhen YI Fang Blister Packaging Co., Ltd. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232791 — Access Intact PTH | Beckman Coulter, Inc. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231778 — Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231365 — Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves | Anhui Intco Medical Products Co., Ltd. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232040 — Gynatrof | Tyros Biopharma, Inc. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232316 — DEKA Infusion System, DEKA Administration Set | Deka Research and Development Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233862 — NUNA LUX (NUNL528) | Premier North America, Inc. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233030 — BoneMRI | Mriguidance B.V. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231690 — iCAS-LV | Highrad , Ltd. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240083 — GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232328 — Insignis Syringe Infusion System | Innovative Health Sciences, LLC Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233095 — S21 OTC Transcutaneous Electrical Nerve Stimulator | Micro Current Technology, Inc. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231915 — Zfx Abutments | Zfx GmbH - A Company of Zimvie Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231648 — Muscle Stimulator | Shenzhen Yiran Intelligent Co., Ltd. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233410 — LIAISON PLEX Respiratory Flex Assay | Luminex Corporation Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232828 — IMAGEnet6 Ophthalmic Data System | Topcon Corporation Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232385 — OxiplexTS200 | Iss Medical, Inc. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240277 — MiroDry Wound Matrix | Reprise Biomedical, Inc. Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231683 — inHEART Models | Inheart, Sas Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230837 — PlazMagik | Agnes Medical Co., Ltd. Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240244 — NPseal (Small, Medium, Large) | Guard Medical, Inc. Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240268 — Accu-Joint Hemi Implant | Accufix Surgical, Inc. Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232842 — Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240051 — Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232765 — MAGNETOM Cima.X Fit | Siemens Medical Solutions USA, Inc. Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit | Bd Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233360 — Curiteva Thoracolumbar Plate System | Curiteva, Inc. Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232971 — APRO 55 Catheter and Alembic Aspiration Tubing | Alembic, LLC Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232613 — CT Cardiomegaly | Innolitics, LLC Wed Feb 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230024 — Technozym ADAMTS13 Activity | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM Wed Feb 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232562 — PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. Wed Feb 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233830 — OsteoCool 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. Wed Feb 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233488 — Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. Wed Feb 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232885 — Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd Wed Feb 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231845 — Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. Wed Feb 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222400 — Coresculpt & Magsculpt | K1Med Co., Ltd. Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |