510(k) Clearances — Page 98
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243259 — MASADA Modular Spinal Fixation System | Astura Medical Tue Jan 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242019 — GXR-Series Diagnostic X-Ray System | DRGEM Corporation Tue Jan 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241079 — uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. Tue Jan 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242588 — COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | OrbusNeich Medical (Shenzhen) Co., Ltd. Tue Jan 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242488 — Soteria E-View | Omega Medical Imaging, LLC Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242123 — Brainomix 360 e-CTA | Brainomix Limited Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242760 — WHILL Model R | Whill, Inc. Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243466 — Conformity Stem Extension Line, #0 | United Orthopedic Corporation Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243481 — TMINI Miniature Robotic System | THINK Surgical, Inc. Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242753 — SD TL Implant System | Arum Dentistry Co., Ltd. Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241904 — DermiSphere Dermal Template | Fesariustherapeutics, Inc. Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242139 — Mobility Scooter (YL-09B, YL-07) | Yongkang Yile Vehicle Co., Ltd. Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242119 — INNOVISION-EXII | Dk Medical System Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241757 — syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240346 — NobelProcera Zirconia Implant Bridge | Nobel Biocare AB Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243737 — Inbella RF System | Inbella Medical, Inc. Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233118 — DUET-V (Model: ESK-3261DV) | Eunsung Global Corp Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242726 — Synapsys VHIT | Inventis S.R.L. Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242578 — EVOLVE Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243363 — JLK-ICH | JLK, Inc. Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241283 — Elemental Granulate | Zinkh NV Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241350 — Clarify DL | Ge Medical Systems Israel, Functional Imaging Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250015 — Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | Ormco Corporation Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233419 — GBR System | Proimtech Saglik Urunleri Anonim Sirketi Fri Jan 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242334 — Ezra Flash | Ezra Ai, Inc. Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242789 — Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) | Dongguan Laiguang Electronic Technology Co., Ltd. Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243049 — Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242448 — Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) | Anhui Jbh Medical Apparatus Co., Ltd. Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241568 — CrystLCare PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical, Inc. Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241696 — Ortho AI | Ortho Ai, LLC Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241005 — Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. Thu Jan 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242468 — Power Wheelchair (D10, D12, D15, D17, D20, D37) | Anhui Jbh Medical Apparatus Co., Ltd. Tue Dec 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241338 — Peak Flow Meter | Chongqing Moffy Innovation Technology Co., Ltd. Tue Dec 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) | Genadyne Biotechnologies, Inc. Tue Dec 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243670 — Idys® LIF | Clariance Tue Dec 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242989 — Electric Wheelchair (MODEL H) | Nanjing E-Take Medical Apparatus Co., Ltd. Tue Dec 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241852 — Nasal Aspirator (NS 13) | Avita Corporation Tue Dec 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243224 — MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) | ABBOTT MEDICAL Tue Dec 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243394 — AF531 Oro-Nasal SE Face Mask | Respironics, Inc. Mon Dec 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243445 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. Mon Dec 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242376 — Next Generation Access Platform | Balt USA, LLC Mon Dec 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242804 — PAL Aspiration System | Microaire Surgical Instruments, LLC Mon Dec 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233119 — 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | Shenzhen Beacon Display Technology Co., Ltd. Sat Dec 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243835 — TiLink-P SI Joint Fusion System | SurGenTec, LLC Fri Dec 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240828 — OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. Fri Dec 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |