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
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance bioMérieux SA Cleared 2026-04-15 Registered with US (FDA)	bioMérieux SA	2026-04-15	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)
End Cap (6701), Sizing Sleeve (6920), Upsizing Sleeve (6925) Medtronic Cardiac Rhythm Disease Management Cleared 2026-04-15 Registered with US (FDA)	Medtronic Cardiac Rhythm Disease Management	2026-04-15	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)
ASTar BC G- Kit Q-Linea AB Cleared 2026-04-15 Registered with US (FDA) UK (MHRA)	Q-Linea AB	2026-04-15	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Transvene CS/SVC Lead (6937A) Medtronic, Inc Cleared 2026-04-15 Registered with US (FDA)	Medtronic, Inc	2026-04-15	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)
IDS-iSYS Total Testosterone Immunodiagnostic Systems Limited Cleared 2026-04-15 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Immunodiagnostic Systems Limited	2026-04-15	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
PATH BGC Crossroads Neurovascular, Inc. Cleared 2026-04-15 Registered with US (FDA)	Crossroads Neurovascular, Inc.	2026-04-15	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)
Zilver Vena Venous Self-Expanding Stent Cook Ireland, Ltd. Cleared 2026-04-14 Registered with US (FDA) Canada (Health Canada)	Cook Ireland, Ltd.	2026-04-14	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HD 8Ch Wrist Array Shenzhen RF Tech Co., Ltd. Cleared 2026-04-14 Registered with US (FDA) UK (MHRA)	Shenzhen RF Tech Co., Ltd.	2026-04-14	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Inbentus Versatile Iconic Solutions by Murcia, SL Cleared 2026-04-14 Registered with US (FDA)	Iconic Solutions by Murcia, SL	2026-04-14	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)
TriMemo™ SEMIRIGID ANNULOPLASTY RING Corcym Srl Cleared 2026-04-14 Registered with US (FDA)	Corcym Srl	2026-04-14	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)
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) Shenzhen Dongjiang Technology Co., Ltd. Cleared 2026-04-14 Registered with US (FDA)	Shenzhen Dongjiang Technology Co., Ltd.	2026-04-14	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)
SPRINT PNS System Spr Therapeutics, LLC Cleared 2026-04-14 Registered with US (FDA)	Spr Therapeutics, LLC	2026-04-14	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)
Equinoxe® Shoulder System Exactech, Inc. Cleared 2026-04-14 Registered with US (FDA)	Exactech, Inc.	2026-04-14	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)
Zilver® Flex® 35 Vascular Stent; Zilver® 635® Vascular Stent; Zilver® 518® Vascular Stent Cook Ireland, Ltd. Cleared 2026-04-14 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Cook Ireland, Ltd.	2026-04-14	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) Kestra Medical Technologies, Inc. Cleared 2026-04-14 Registered with US (FDA)	Kestra Medical Technologies, Inc.	2026-04-14	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)
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) Unimed Medical Supplies, Inc. Cleared 2026-04-14 Registered with US (FDA)	Unimed Medical Supplies, Inc.	2026-04-14	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)
Critical Care Suite with Enteric Tube Positioning AI Algorithm Ge Medical Systems, Inc. Cleared 2026-04-14 Registered with US (FDA)	Ge Medical Systems, Inc.	2026-04-14	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)
Elecsys Anti-SARS-CoV-2 S Roche Diagnostics GmbH Cleared 2026-04-13 Registered with US (FDA) UK (MHRA)	Roche Diagnostics GmbH	2026-04-13	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
PulseSelect Pulse Field Ablation (PFA) Catheter Medtronic, Inc Cleared 2026-04-13 Registered with US (FDA)	Medtronic, Inc	2026-04-13	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)
b-ONE® Bipolar Head B-One Ortho, Corp. Cleared 2026-04-13 Registered with US (FDA)	B-One Ortho, Corp.	2026-04-13	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)
Inset Reverse Total Shoulder System Shoulder Innovations, LLC Cleared 2026-04-13 Registered with US (FDA)	Shoulder Innovations, LLC	2026-04-13	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)
Aventus Introducer Sheath Inquis Medical Cleared 2026-04-13 Registered with US (FDA)	Inquis Medical	2026-04-13	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 Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) Zimmer Inc Cleared 2026-04-13 Registered with US (FDA)	Zimmer Inc	2026-04-13	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)
Heal-Check Rapid COVID-19 Antigen Self-Test Healgen Scientific, LLC Cleared 2026-04-13 Registered with US (FDA)	Healgen Scientific, LLC	2026-04-13	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)
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES Hc Biologics, LLC Cleared 2026-04-13 Registered with US (FDA)	Hc Biologics, LLC	2026-04-13	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)
CVAC Aspiration System Calyxo, Inc. Cleared 2026-04-13 Registered with US (FDA)	Calyxo, Inc.	2026-04-13	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)
ACORYS MAPPING SYSTEM Corify Care S.L Cleared 2026-04-13 Registered with US (FDA) UK (MHRA)	Corify Care S.L	2026-04-13	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HVT 2.0 Vapotherm, Inc. Cleared 2026-04-13 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Vapotherm, Inc.	2026-04-13	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) 1987 Media Limited Cleared 2026-04-10 Registered with US (FDA)	1987 Media Limited	2026-04-10	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)
LOBO Vascular Occlusion System Okami Medical Cleared 2026-04-10 Registered with US (FDA)	Okami Medical	2026-04-10	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)
DIACORE ShenB Co., Ltd. Cleared 2026-04-10 Registered with US (FDA) EU (EUDAMED)	ShenB Co., Ltd.	2026-04-10	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
ShaeferH Shaeferh, LLC Cleared 2026-04-10 Registered with US (FDA)	Shaeferh, LLC	2026-04-10	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)
Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads Covidien (Part of Medtronic) Cleared 2026-04-10 Registered with US (FDA)	Covidien (Part of Medtronic)	2026-04-10	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)
ABL90 FLEX PLUS System, safeCLINITUBES Radiometer Medicals Aps Cleared 2026-04-10 Registered with US (FDA)	Radiometer Medicals Aps	2026-04-10	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)
CoAptix S System University of Utah, Department of Orthopaedics Cleared 2026-04-10 Registered with US (FDA)	University of Utah, Department of Orthopaedics	2026-04-10	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)
DeepBT Detector-Plus Aitewan Biomedical Technology, Inc. Cleared 2026-04-10 Registered with US (FDA)	Aitewan Biomedical Technology, Inc.	2026-04-10	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)
VRNT Cognifisense, Inc. Cleared 2026-04-10 Registered with US (FDA)	Cognifisense, Inc.	2026-04-10	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)
Overjet Iris Intelligent Imaging System Overjet, Inc. Cleared 2026-04-10 Registered with US (FDA) UK (MHRA)	Overjet, Inc.	2026-04-10	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Protaryx Transseptal Puncture Device (PTX2-001) Protaryx Medical, Inc. Cleared 2026-04-10 Registered with US (FDA)	Protaryx Medical, Inc.	2026-04-10	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)
Relu Cloud Relu BV Cleared 2026-04-10 Registered with US (FDA) EU (EUDAMED)	Relu BV	2026-04-10	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
SMART Osteotomy System Actis Medical Pty Ltd Cleared 2026-04-10 Registered with US (FDA)	Actis Medical Pty Ltd	2026-04-10	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)
AI-Rad Companion Organs RT Siemens Healthcare GmbH Cleared 2026-04-10 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Siemens Healthcare GmbH	2026-04-10	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
TherOx Downstream System Zoll Circulation Cleared 2026-04-10 Registered with US (FDA)	Zoll Circulation	2026-04-10	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)
Auryon Atherectomy System Eximo Medical, Ltd. Cleared 2026-04-10 Registered with US (FDA) UK (MHRA) AU (TGA)	Eximo Medical, Ltd.	2026-04-10	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
CeQur Simplicity™ On-Demand Insulin Delivery System Cequr SA Cleared 2026-04-10 Registered with US (FDA)	Cequr SA	2026-04-10	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)
syngo Dynamics (VA41F) Siemens Healthcare GmbH Cleared 2026-04-10 Registered with US (FDA)	Siemens Healthcare GmbH	2026-04-10	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)
TRIOS Dx (R1) 3Shape TRIOS AS Cleared 2026-04-10 Registered with US (FDA)	3Shape TRIOS AS	2026-04-10	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)
Freestyle Mini Hands-free Medela, Inc. Cleared 2026-04-10 Registered with US (FDA) Canada (Health Canada)	Medela, Inc.	2026-04-10	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Teleport Glide Microcatheter OrbusNeich Medical (Shenzhen) Co., Ltd. Cleared 2026-04-10 Registered with US (FDA)	OrbusNeich Medical (Shenzhen) Co., Ltd.	2026-04-10	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 Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder Becton Dickinson and Company Cleared 2026-04-10 Registered with US (FDA)	Becton Dickinson and Company	2026-04-10	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)