510(k) Clearances — Page 65
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243647 — Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251000 — Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) | Shenzhen Chuangtong Yigou Technology Co., Ltd. Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251088 — Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250972 — Primum Hydrophilic Guiding Catheter | Pendracare Sun Jun 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243130 — Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251642 — Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243682 — SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250648 — Philips iCT CT system | Philips Medical Systems Nederland B.V. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250585 — LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251210 — Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251431 — FIX-C PEEK ACIF SA System | Jeil Medical Corporation Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250984 — Maestro System (REF100) | Moon Surgical Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243077 — Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251660 — T3 Pro Implants ZimVie Packaging System | Biomet 3i, LLC Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243388 — Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250828 — CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251654 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243900 — eMotus Respiratory Motion Management System | Empnia, Inc. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243816 — Testa TP Pivoting Spacer System | Spine Wave, Inc. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242988 — Genostis Osteosynthesis System | Genostis AF Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251329 — Diode laser device (RF3120-BI) | Risu Medical Technology Co., Ltd. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250522 — Multi4 System | Multi4 Medical AB Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250310 — VIKING Fixed Curve Diagnostic Catheter | Boston Scientific Corporation Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251116 — Luja Coudé | Coloplast Corp. Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243183 — RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250940 — Atmo Gas Capsule System | Atmo Biosciences, Ltd. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243079 — NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical , Ltd. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242846 — Doppler FHR Detector (BF-500D+, BF-560) | Shenzhen Bestman Instrument Co., Ltd. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250519 — Lap.Ox Laparoscopic Tissue Oximeter | ViOptix, Inc. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250956 — HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243175 — Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243275 — Equinoxe® Scapula Fracture System | Exactech, Inc. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251728 — Velacur One (LI-1100) | Sonic Incytes Medical Corp Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250548 — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co. , Ltd. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243636 — Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243391 — AISight Dx | PathAI, Inc. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243179 — Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250929 — TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | TriMed, Inc. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250967 — Sherlock | Open Implants, LLC Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251717 — Freedom® Total Knee System Titanium Tibial Base Plate | Maxx Orthopedics, Inc. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251395 — The Rialto SI Fusion System | Medtronic Sofamor Danek USA, Inc. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251694 — safety lancet | Tianjin Huahong Technology Co., Ltd. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251632 — Optimas MAX System | InMode , Ltd. Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251613 — SwissGraft X | Geistlich Pharma AG Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |