510(k) Clearances — Page 66
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Smith & Nephew, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250747 — Globe® Pulsed Field System | Kardium, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251606 — Power Wheelchair (D26) | Anhui Jbh Medical Apparatus Co., Ltd. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242845 — EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250302 — Flexible Partial Resin | Prismatik Dentalcraft, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | PAJUNK GmbH Medizintechnologie Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | Fisher & Paykel Healthcare, Ltd. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251725 — ANAX OCT Spinal System | Cg Medtech Co., Ltd. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250966 — CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251003 — X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243112 — Curapuls 670 | Enraf-Nonius, B.V. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250329 — GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251362 — PediFlex Flexible Nail System | OrthoPediatrics Corp. Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | Spectrum Medical S.R.L. Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243009 — MIST IC | Imagine Milling Technologies, LLC Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250268 — HyperSnap Surgical System (HSS) | Hypervision Surgical Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251648 — GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251358 — Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251644 — ProAM ALIF System | Pro Surgical, Inc. Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242924 — OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250143 — Digital Prism Correction Feature (DPCF) | Apple, Inc. Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | Olympus Medical Systems Corp. Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243142 — Cranial 4Pi Immobilization | Brainlab AG Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251271 — TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250885 — Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243339 — WiTOF | Idmed Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251570 — Hippocampe Marathon and Trail | Vipamat Sarl Mon Jun 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242981 — Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | Sophysa Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243168 — Alinity i Rubella IgG | Abbott Laboratories Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251567 — NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242911 — Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242985 — CollOvine Wound Dressing | Ovigenex, LLC Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243589 — PAL Sterilization Case | Microaire Surgical Instruments, LLC Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251114 — FloPatch FP120 | Flosonics Medical Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250732 — Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250877 — TMINI Miniature Robotic System | THINK Surgical, Inc. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243398 — CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242964 — Celsi Warmer | Hadleigh Health Technologies Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251224 — Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243120 — HybridAPC probe | Erbe Elektromedizin GmbH Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |