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
Cartesion Prime (PCD-1000A/3) V10.21 Canon Medical Systems Corporation Cleared 2025-12-01 Registered with US (FDA)	Canon Medical Systems Corporation	2025-12-01	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)
CT VScore+ Canon Medical Informatics Inc Cleared 2025-11-28 Registered with US (FDA)	Canon Medical Informatics Inc	2025-11-28	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)
IsoPSA Assay Cleveland Diagnostics, Inc. Cleared 2025-11-28 Registered with US (FDA)	Cleveland Diagnostics, Inc.	2025-11-28	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)
Dendrite Imaging System Dendrite Imaging, Inc. Cleared 2025-11-28 Registered with US (FDA)	Dendrite Imaging, Inc.	2025-11-28	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)
Medical Diode Laser Systems (TR-B) Baoding Te'Anzhou Electronic Technology Co., Ltd. Cleared 2025-11-28 Registered with US (FDA)	Baoding Te'Anzhou Electronic Technology Co., Ltd.	2025-11-28	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)
Sophy Mini Monopressure Valve (SM1) Sophysa SA Cleared 2025-11-28 Registered with US (FDA)	Sophysa SA	2025-11-28	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)
Carriere® Motion Pro® Clear Bite Corrector Ortho Organizers, Inc. Cleared 2025-11-27 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Ortho Organizers, Inc.	2025-11-27	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter Surgical Instrument Service and Savings, Inc. Cleared 2025-11-26 Registered with US (FDA)	Surgical Instrument Service and Savings, Inc.	2025-11-26	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)
uDR Arria & uDR Aris Shanghai United Imaging Healthcare Co., Ltd. Cleared 2025-11-26 Registered with US (FDA)	Shanghai United Imaging Healthcare Co., Ltd.	2025-11-26	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)
RELIEEV HSG Catheter (HSG7FA1) Li Medical Corporation , Ltd. Cleared 2025-11-26 Registered with US (FDA)	Li Medical Corporation , Ltd.	2025-11-26	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)
Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip Acon Laboratories, Inc. Cleared 2025-11-26 Registered with US (FDA)	Acon Laboratories, Inc.	2025-11-26	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)
Tru Kidney Health Test Panel; Tru Analyzer Truvian Health Cleared 2025-11-26 Registered with US (FDA)	Truvian Health	2025-11-26	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)
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing Sb-Kawasumi Laboratories, Inc. Cleared 2025-11-26 Registered with US (FDA)	Sb-Kawasumi Laboratories, Inc.	2025-11-26	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)
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device Medical Wire & Equipment Company (Bath), Ltd. Cleared 2025-11-26 Registered with US (FDA)	Medical Wire & Equipment Company (Bath), Ltd.	2025-11-26	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)
Vanquish Water Vapor Ablation Device Francis Medical, Inc. Cleared 2025-11-26 Registered with US (FDA)	Francis Medical, Inc.	2025-11-26	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)
OEC One CFD Ge Hualun Medical Systems Co. , Ltd. Cleared 2025-11-26 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Ge Hualun Medical Systems Co. , Ltd.	2025-11-26	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
MuReva OM™ Mureva Phototherapy, Inc. Cleared 2025-11-26 Registered with US (FDA)	Mureva Phototherapy, Inc.	2025-11-26	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)
0.014" Willow Guidewire Arbor Endovascular, LLC Cleared 2025-11-26 Registered with US (FDA)	Arbor Endovascular, LLC	2025-11-26	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)
CEREC Tessera Abutment System Dentsply Sirona Cleared 2025-11-26 Registered with US (FDA)	Dentsply Sirona	2025-11-26	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)
Fenom Flo™ FeNO Monitoring System Mgc Diagnostics Corporation Cleared 2025-11-26 Registered with US (FDA)	Mgc Diagnostics Corporation	2025-11-26	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)
enCore Night Guard Encore Guards Cleared 2025-11-25 Registered with US (FDA)	Encore Guards	2025-11-25	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)
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) Dongguan Lide Electric Appliance Co., Ltd. Cleared 2025-11-25 Registered with US (FDA)	Dongguan Lide Electric Appliance Co., Ltd.	2025-11-25	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)
LuxCreo Flexible Partial Denture Resin Luxcreo, Inc. Cleared 2025-11-25 Registered with US (FDA)	Luxcreo, Inc.	2025-11-25	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)
Scaida BrainCT-ICH (v1.0) Mlhealth 360 Cleared 2025-11-25 Registered with US (FDA)	Mlhealth 360	2025-11-25	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)
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) Esaote, S.P.A. Cleared 2025-11-25 Registered with US (FDA)	Esaote, S.P.A.	2025-11-25	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)
PennPET Explorer Positron Emission Tomograph Trustees of the University of Pennsylvania Cleared 2025-11-25 Registered with US (FDA)	Trustees of the University of Pennsylvania	2025-11-25	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)
RCT700 Ray Co., Ltd. Cleared 2025-11-25 Registered with US (FDA)	Ray Co., Ltd.	2025-11-25	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)
LeafPure-Echo (LM-LPNdA) SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD. Cleared 2025-11-25 Registered with US (FDA)	SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD.	2025-11-25	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)
Spectra Platinum Uzinmedicare Co. Cleared 2025-11-25 Registered with US (FDA)	Uzinmedicare Co.	2025-11-25	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)
BELLUS-Q Speclipse, Inc. Cleared 2025-11-25 Registered with US (FDA) EU (EUDAMED)	Speclipse, Inc.	2025-11-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
HALO AP Dx Indica Labs Cleared 2025-11-25 Registered with US (FDA)	Indica Labs	2025-11-25	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)
Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® Geistlich-Pharma Cleared 2025-11-25 Registered with US (FDA)	Geistlich-Pharma	2025-11-25	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)
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) Olympus Medical Systems Corporation Cleared 2025-11-25 Registered with US (FDA)	Olympus Medical Systems Corporation	2025-11-25	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)
Hushd Avera Good Sleep CO Pte , Ltd. Cleared 2025-11-25 Registered with US (FDA)	Good Sleep CO Pte , Ltd.	2025-11-25	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)
Medusa Orthopedics Boa External Fixation System Medusa Orthopedics, LLC Cleared 2025-11-25 Registered with US (FDA)	Medusa Orthopedics, LLC	2025-11-25	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)
XPS™ with Steen Solution™ Perfusate Xvivo Perfusion AB Cleared 2025-11-25 Registered with US (FDA)	Xvivo Perfusion AB	2025-11-25	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)
NX01 (NX01) Naox Technologies Sas Cleared 2025-11-25 Registered with US (FDA)	Naox Technologies Sas	2025-11-25	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)
Lumicell Direct Visualization System (DVS) Lumicell, Inc. Cleared 2025-11-25 Registered with US (FDA)	Lumicell, Inc.	2025-11-25	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)
Eva Scalp Cooling System Stemtech Medical Devices Private Limited Cleared 2025-11-25 Registered with US (FDA)	Stemtech Medical Devices Private Limited	2025-11-25	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)
ZSFab Lumbar Interbody System Zsfab, Inc. Cleared 2025-11-25 Registered with US (FDA)	Zsfab, Inc.	2025-11-25	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)
FEops HEARTguide Simulation Application Feops NV Cleared 2025-11-25 Registered with US (FDA) UK (MHRA)	Feops NV	2025-11-25	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Akura Thrombectomy System Akura Medical Cleared 2025-11-25 Registered with US (FDA)	Akura Medical	2025-11-25	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)
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) Eurosets Srl Cleared 2025-11-24 Registered with US (FDA)	Eurosets Srl	2025-11-24	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)
Dakota LP System Precision Spine, Inc. Cleared 2025-11-24 Registered with US (FDA)	Precision Spine, Inc.	2025-11-24	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)
a2z-Unified-Triage A2z Radiology Ai, Inc. Cleared 2025-11-24 Registered with US (FDA)	A2z Radiology Ai, Inc.	2025-11-24	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)
BCM2-Body Composition Monitor Fresenius Medical Care Renal Therapies Group, LLC Cleared 2025-11-24 Registered with US (FDA)	Fresenius Medical Care Renal Therapies Group, LLC	2025-11-24	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)
Envision Mammography Platform Hologic Inc Cleared 2025-11-24 Registered with US (FDA)	Hologic Inc	2025-11-24	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)
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) F Care Systems USA, LLC Cleared 2025-11-24 Registered with US (FDA)	F Care Systems USA, LLC	2025-11-24	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)
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Cleared 2025-11-24 Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	2025-11-24	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)
Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Cleared 2025-11-24 Registered with US (FDA)	Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.	2025-11-24	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)