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.

3,400 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
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)
FoundationOne Liquid CDx Foundation Medicine, Inc. Cleared 2026-05-27 Registered with US (FDA) UK (MHRA) AU (TGA)	Foundation Medicine, Inc.	2026-05-27	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	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)
Glucommander Glytec, LLC Cleared 2026-05-27 Registered with US (FDA)	Glytec, LLC	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)
FoundationOne CDx (F1CDx) Foundation Medicine, Inc. Cleared 2026-05-27 Registered with US (FDA)	Foundation Medicine, 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)
Oxford Partial Knee System; Cementless Oxford™Partial Knee System Biomet Manufacturing, Inc. Cleared 2026-05-27 Registered with US (FDA)	Biomet Manufacturing, 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)
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)
Edwards EVOQUE Loading System and Trimmer, Model 9850LSB Edwards Lifesciences, LLC Cleared 2026-05-26 Registered with US (FDA) AU (TGA)	Edwards Lifesciences, LLC	2026-05-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	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)
VISUMAX 800 Femtosecond Laser Carl Zeiss Meditec AG Cleared 2026-05-26 Registered with US (FDA)	Carl Zeiss Meditec AG	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)
Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna™ SCS IPG Abbott Medical Cleared 2026-05-26 Registered with US (FDA)	Abbott Medical	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)
LIAISON QuantiFERON TB Gold Plus II; LIAISON Control QuantiFERON TB Gold Plus II DiaSorin, Inc. Cleared 2026-05-26 Registered with US (FDA)	DiaSorin, 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)
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)
Onyx™ Liquid Embolic System (LES) Ev3 Neurovascular Cleared 2026-05-26 Registered with US (FDA)	Ev3 Neurovascular	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-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)
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)
coflex Interlaminar Stabilization Device Companion Spine France SAS Cleared 2026-05-22 Registered with US (FDA)	Companion Spine France SAS	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)
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning Canon Medical Informatics Inc Cleared 2026-05-22 Registered with US (FDA)	Canon Medical Informatics 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)
eXaSkin Plus Anatomical Geometry, SL Cleared 2026-05-22 Registered with US (FDA)	Anatomical Geometry, SL	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)
AiSteth® Ai Health Highway India Pvt., Ltd. Cleared 2026-05-22 Registered with US (FDA)	Ai Health Highway India Pvt., 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)
Apollo TMS Therapy System;Apollo light TMS Therapy System Mag & More GmbH Cleared 2026-05-22 Registered with US (FDA)	Mag & More GmbH	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)
Ion-C Navigation Instruments SurGenTec, LLC Cleared 2026-05-22 Registered with US (FDA)	SurGenTec, LLC	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)
Atmo Gas Capsule System Atmo Biosciences, Ltd. Cleared 2026-05-22 Registered with US (FDA) AU (TGA)	Atmo Biosciences, Ltd.	2026-05-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE Tz Medical, Inc. Cleared 2026-05-22 Registered with US (FDA)	Tz Medical, 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)
uMR Astra Shanghai United Imaging Healthcare Co., Ltd. Cleared 2026-05-22 Registered with US (FDA)	Shanghai United Imaging Healthcare 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)
PCWP Analysis Software Cardiosense, Inc. Cleared 2026-05-22 Registered with US (FDA)	Cardiosense, 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)
InQwire Amplatz Guide Wire Merit Medical Ireland, Ltd. Cleared 2026-05-22 Registered with US (FDA)	Merit Medical Ireland, 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)
Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System Abbott Vascular, Inc. Cleared 2026-05-22 Registered with US (FDA)	Abbott Vascular, 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)
MagVenture Accelerated TMS (aTMS) Therapy System Tonica Elektronik A/S Cleared 2026-05-22 Registered with US (FDA)	Tonica Elektronik A/S	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)
Zenith Distal Access Long Sheath Suzhou Zenith Vascular SciTech Limited Cleared 2026-05-22 Registered with US (FDA)	Suzhou Zenith Vascular SciTech Limited	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)
XIENCE Alpine™, XIENCE Sierra™, XIENCE PRO™ S, and XIENCE Skypoint™ Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc. Cleared 2026-05-22 Registered with US (FDA)	Abbott Vascular, 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)