510(k) Clearances — Page 73
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. Thu May 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250532 — Solawave 2-in-1 Skincare Mini (Model: 61043) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Thu May 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC Thu May 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243116 — FlareHawk Interbody Fusion System | Integrity Implants Inc. Dba Accelus Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243793 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242857 — ClearHemograsper | Finemedix Co., Ltd. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250798 — Control-IQ+ technology | Tandem Diabetes Care, Inc. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243122 — uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250528 — Stryker AlphaVent Knotless SP Biocomposite Anchor | Stryker Endoscopy Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243866 — InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243429 — HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251239 — GrandioSO Unlimited | Voco GmbH Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250493 — MotiliCap GI Monitoring System | Anx Robotica Corporation Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251109 — SMARTDent | Ray Co., Ltd. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243762 — Synapse 3D Base Tools (V7.0) | Fujifilm Corporation Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243302 — 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251276 — Swoop® Portable MR Imaging® System | Hyperfine, Inc. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242637 — MEM Clear Aligner System | Mem Dental Technology Co., Ltd. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251230 — The Alma Hybrid Laser System | Alma Lasers, Inc. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242527 — The Karma® Fixation System | Spinal Elements, Inc. Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250602 — X-PAC® N-GAGE Lumbar Plate System | Expanding Innovations, Inc. Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242485 — EveryWare | Breas Medical AB Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250370 — SCENARIA View Phase 5.0 | Fujifilm Corporation Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250199 — VitalFlow Console | Medtronic, Inc. Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250489 — FP3D | Keystone Industries Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250534 — Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250866 — Sovereign Posterior Cervical System | Met One Technologies, LLC Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | Flexicare Medical Limited. Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251231 — ViewFlex X ICE Catheter, Sensor Enabled | ABBOTT MEDICAL Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250122 — SleepRight Snore Aid | Splintek, Inc. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250038 — Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243301 — MapRT | Vision Rt, Ltd. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243643 — restor3d Reverse Total Shoulder Arthroplasty System | Restor3D Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250456 — Dentemp Pro-Comfort Dental Guard | Doc Brands, Inc. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250390 — CloSYS® Dry Mouth Sensitive Mouth Rinse | Rowpar Pharmaceuticals, Inc. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242755 — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company , Ltd. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243411 — Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243601 — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250020 — Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. Mon May 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241671 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241581 — Hemodialysis Catheter | Haolang Medical USA Corporation Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250971 — Embosphere Microspheres | Biosphere Medical, S.A. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242585 — Cystatin C | SENTINEL CH. SpA Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242731 — MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243105 — Ruby Intravascular Catheter | Venocare, Inc. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243617 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |