Recently FDA-cleared medical devices

Every device we hold with a US FDA 510(k) clearance decided in the last 12 months, newest first. Each one links through to its full regulatory record.

3,708 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device	Manufacturer	Cleared	US	UK	CA	AU	EU
CoSense ETCO Monitor Capnia, Inc. Cleared 2026-05-29 Registered with US (FDA) Canada (Health Canada)	Capnia, Inc.	2026-05-29	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Ulike Clear Zero (YC10 BU) Guangxi Ulike Medical Technology Co., Ltd. Cleared 2026-05-28 Registered with US (FDA)	Guangxi Ulike Medical Technology Co., Ltd.	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Trexon™ Monofilament Synthetic Absorbable Suture Medtronic, Inc Cleared 2026-05-28 Registered with US (FDA)	Medtronic, Inc	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N Bioptimal International PTE LTD Cleared 2026-05-28 Registered with US (FDA)	Bioptimal International PTE LTD	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Helio Kids; Apex P Motion Composites Cleared 2026-05-28 Registered with US (FDA)	Motion Composites	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BD BACTEC FXI Culture System Bd Diagnostic Systems Cleared 2026-05-28 Registered with US (FDA)	Bd Diagnostic Systems	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AmplatzerTM PFO Occluder; AmplatzerTM Talisman™ PFO Occluder Abbott Medical Cleared 2026-05-28 Registered with US (FDA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BMD Titanium Spinal Fusion System Global Biomedica sro Cleared 2026-05-28 Registered with US (FDA)	Global Biomedica sro	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Dukal Crepe Paper Sterilization Wrap DUKAL LLC Cleared 2026-05-28 Registered with US (FDA)	DUKAL LLC	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AmplatzerTM Muscular VSD Occluder Abbott Medical Cleared 2026-05-28 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Bellalun 2D (VDMS-1000S) Vieworks Co., Ltd. Cleared 2026-05-28 Registered with US (FDA)	Vieworks Co., Ltd.	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
780 nm SPY Portable Handheld Imaging (SPY-PHI) System Stryker Endoscopy Cleared 2026-05-28 Registered with US (FDA)	Stryker Endoscopy	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Woven EndoBridge (WEB) Aneurysm Embolization System Microvention, Inc. Cleared 2026-05-28 Registered with US (FDA)	Microvention, Inc.	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AmplatzerTM Duct Occluder Abbott Medical Cleared 2026-05-28 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Abbott RealTime IDH1 Abbott Molecular, Inc. Cleared 2026-05-28 Registered with US (FDA)	Abbott Molecular, Inc.	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Abbott RealTime IDH2 Abbott Molecular, Inc. Cleared 2026-05-28 Registered with US (FDA)	Abbott Molecular, Inc.	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ANDI 2.2 Imeka Solutions, Inc. Cleared 2026-05-28 Registered with US (FDA)	Imeka Solutions, Inc.	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Disposable Endoscopic Distal Attachments Yangzhou Fartley Medical Instrument Technology Co,., Ltd. Cleared 2026-05-28 Registered with US (FDA) AU (TGA)	Yangzhou Fartley Medical Instrument Technology Co,., Ltd.	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
STIMPOD NMS460 Nerve Stimulator Algiamed Technologies USA, Inc. Cleared 2026-05-28 Registered with US (FDA)	Algiamed Technologies USA, Inc.	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Zimmer Persona Personalized Knee System Zimmer Inc Cleared 2026-05-28 Registered with US (FDA)	Zimmer Inc	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AMPLATZER SEPTAL OCCLUDER Abbott Medical Cleared 2026-05-28 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Synapse Lung Nodule AI FUJIFILM Corporation Cleared 2026-05-27 Registered with US (FDA)	FUJIFILM Corporation	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Helion Viewer Suite Videomed Srl ( a Baxter Healthcare Corp company) Cleared 2026-05-27 Registered with US (FDA)	Videomed Srl ( a Baxter Healthcare Corp company)	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Renasys Edge (66803126) Smith & Nephew Medical, Ltd. Cleared 2026-05-27 Registered with US (FDA)	Smith & Nephew Medical, Ltd.	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Portable Dental X-ray System Model PDX nova PDX Co., Ltd. Cleared 2026-05-27 Registered with US (FDA)	PDX Co., Ltd.	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems Philips Ultrasound, Inc. Cleared 2026-05-27 Registered with US (FDA)	Philips Ultrasound, Inc.	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
EPIQ Series Diagnostic Ultrasound System Philips Ultrasound, Inc. Cleared 2026-05-27 Registered with US (FDA)	Philips Ultrasound, Inc.	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LigaPASS™ System Medicrea International Cleared 2026-05-27 Registered with US (FDA)	Medicrea International	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Visby Medical Flu and COVID-19 Test Visby Medical Cleared 2026-05-27 Registered with US (FDA)	Visby Medical	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Dione PEEK Screw System ZheJiang Decans Medical Devices Co., Ltd. Cleared 2026-05-27 Registered with US (FDA)	ZheJiang Decans Medical Devices Co., Ltd.	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
StimelMD (SSMD) system Motion Informatics ltd. Cleared 2026-05-27 Registered with US (FDA)	Motion Informatics ltd.	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ResScan Essentials ResMed PTY Ltd Cleared 2026-05-27 Registered with US (FDA) UK (MHRA)	ResMed PTY Ltd	2026-05-27	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Multimodality Simulation Workspace (MM Sim) (v1.0.0) Philips Medical Systems Nederland BV Cleared 2026-05-27 Registered with US (FDA)	Philips Medical Systems Nederland BV	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
XR-Series (XR-10, XR-20) Automated Hematology Analyzers SYSMEX AMERICA, INC. Cleared 2026-05-27 Registered with US (FDA)	SYSMEX AMERICA, INC.	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AQUA Laminoplasty Systems ZheJiang Decans Medical Devices Co., Ltd. Cleared 2026-05-27 Registered with US (FDA)	ZheJiang Decans Medical Devices Co., Ltd.	2026-05-27	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GORE VIABAHN ENDOPROSTHESIS & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE W. L. Gore and Associates, Inc. Cleared 2026-05-26 Registered with US (FDA)	W. L. Gore and Associates, Inc.	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LOGIQ e GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Cleared 2026-05-26 Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Momcozy Nasal Aspirator (BN007) Shenzhen Root Innovation Technology Co., Ltd. Cleared 2026-05-26 Registered with US (FDA)	Shenzhen Root Innovation Technology Co., Ltd.	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody MEDOS INTERNATIONAL SARL Cleared 2026-05-26 Registered with US (FDA)	MEDOS INTERNATIONAL SARL	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VIVA combo RF System Starmed Co., Ltd. Cleared 2026-05-26 Registered with US (FDA)	Starmed Co., Ltd.	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Digital ClarusScope System, Digital NeuroPEN System CLARUS MEDICAL, LLC Cleared 2026-05-26 Registered with US (FDA)	CLARUS MEDICAL, LLC	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
4K NIR/ICG Imaging System Zhejiang Healnoc Technology CO, LTD Cleared 2026-05-26 Registered with US (FDA)	Zhejiang Healnoc Technology CO, LTD	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM Cerenovus, Inc. Cleared 2026-05-26 Registered with US (FDA)	Cerenovus, Inc.	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
JAZBI™ Resorbable Bone Void Filler Sdip Innovations Pty, Ltd. Cleared 2026-05-26 Registered with US (FDA)	Sdip Innovations Pty, Ltd.	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VisuMax Carl Zeiss Meditec AG Cleared 2026-05-26 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Carl Zeiss Meditec AG	2026-05-26	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
MediBot Needle Driver Uno Parallel Robotics, LLC Cleared 2026-05-24 Registered with US (FDA)	Parallel Robotics, LLC	2026-05-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 CHISON Medical Technologies Co., Ltd. Cleared 2026-05-22 Registered with US (FDA)	CHISON Medical Technologies Co., Ltd.	2026-05-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
DEPUY ATTUNE KNEE SYSTEM DePuy Orthopaedics, Inc. Cleared 2026-05-22 Registered with US (FDA)	DePuy Orthopaedics, Inc.	2026-05-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel VivaChek Biotech (Hangzhou) Co, Ltd Cleared 2026-05-22 Registered with US (FDA)	VivaChek Biotech (Hangzhou) Co, Ltd	2026-05-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
C-beam Pulmera, Inc. Cleared 2026-05-22 Registered with US (FDA)	Pulmera, Inc.	2026-05-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)