510(k) Clearances — Page 99
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241127 — INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. Fri Dec 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243084 — BioTraceIO Precision (2.0) | Techsomed Medical Technologies , Ltd. Fri Dec 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241972 — BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. Fri Dec 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242252 — Power Wheelchair | Anhui Jbh Medical Apparatus Co., Ltd. Fri Dec 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241924 — Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. Fri Dec 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242480 — FLASH EVD System (10-0002) | 7D Surgical ULC Fri Dec 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243037 — Diode Laser System model Dawn-S | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240517 — ProSeal Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243658 — TMC Compression Implant System | Treace Medical Concepts Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243141 — Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) | Jiangxi Medex Technology Co., Ltd. Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232966 — FISIOWARM 7.0 | Golden Star Srl Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243097 — RM STAR EX with RMS Needle | Bomtech Electronics Co., Ltd. Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233252 — Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243677 — iovera° System | Pacira Biosciences, Inc. Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242434 — Insulin Syringes | Chirana T. Injecta Tue Dec 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243623 — SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. Tue Dec 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242573 — NIDO Baby Magnetic Resonance Imaging System | Jiangsu Lici Medical Device Co., Ltd. Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241091 — SIMEOX 200 Airway Clearance Device | Inogen, Inc. Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240975 — Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) | Beijing Taktvoll Technology Co., Ltd. Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) | Belmont Medical Technologies Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240890 — PanopticAI Vital Signs | PanopticAI technologies Limited Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242143 — Angiography Injector | Shandong Int Medical Instruments Co., Ltd. Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243103 — Denture Base | Riton 3D Technology Co., Ltd. Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242782 — GlassBone Granules | Noraker Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243177 — SACS PRO | Elastimed , Ltd. Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243693 — NEO Pedicle Screw System | Neo Medical SA Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241856 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242403 — Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243248 — INHANCE INTACT | Depuy Ireland UC Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242091 — Bolo Button System | Fusion Orthopedics Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242939 — ARTFX Trauma Bone Plate and Screw System | Artfx Medical Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233614 — Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241288 — Noxturnal Web | Nox Medical Ehf Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242948 — Adora DRFi (04550010) | Nrt X-Ray A/S Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242797 — OsteoFlo HydroFiber | SurGenTec, LLC Mon Dec 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243121 — SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; | Jiangxi Medex Technology Co., Ltd. Sun Dec 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243147 — LGO-Surgical Laser Fibers | Light Guide Optics International , Ltd. Sat Dec 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243085 — IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) | Zhuzhou Goldenhot Medical Technology Co., Ltd. Sat Dec 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242688 — Finiff System | Skingrab Co., Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243024 — Cellbrick Knee Spacer | United Orthopedic Corporation Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243293 — Zimmer® Persona® Personalized Knee System | Zimmer Biomet Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243308 — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) | Bonebridge AG Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242530 — HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242953 — KIDS Arterial Filters | Sorin Group Italia S.R.L. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243671 — ExcelsiusGPS® Instruments | Globus Medical, Inc. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242362 — Lightning Viewer | Nexsys Electronics Inc. Dba Medweb Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242572 — TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242929 — Fas Aligner System | Xplora 3D Europe S.L Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233639 — SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. Fri Dec 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |