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
Omnilink Elite Vascular Balloon-Expandable Stent System Abbott Vascular-Cardiac Therapies Cleared 2026-01-12 Registered with US (FDA)	Abbott Vascular-Cardiac Therapies	2026-01-12	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)
Dr. Yglo Skin Tag Remover Theotclab Healthcare B.V. Cleared 2026-01-12 Registered with US (FDA)	Theotclab Healthcare B.V.	2026-01-12	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)
Boston iFace (Boston iFace) Boston Aesthetics, Inc. Cleared 2026-01-12 Registered with US (FDA)	Boston Aesthetics, Inc.	2026-01-12	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)
High speed air turbine handpiece Foshan Topmed Dental Co., Ltd. Cleared 2026-01-12 Registered with US (FDA)	Foshan Topmed Dental Co., Ltd.	2026-01-12	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)
Any-Paste Mediclus Co., Ltd. Cleared 2026-01-12 Registered with US (FDA)	Mediclus Co., Ltd.	2026-01-12	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)
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates Arthrex, Inc. Cleared 2026-01-12 Registered with US (FDA)	Arthrex, Inc.	2026-01-12	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)
EmpowerRide NAVIGATOR Empower Ride, LLC Cleared 2026-01-12 Registered with US (FDA)	Empower Ride, LLC	2026-01-12	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)
SBC1 Cream Sioxmed, LLC Cleared 2026-01-12 Registered with US (FDA)	Sioxmed, LLC	2026-01-12	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)
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) Shenzhen Hingmed Medical Instrument Co., Ltd. Cleared 2026-01-12 Registered with US (FDA)	Shenzhen Hingmed Medical Instrument Co., Ltd.	2026-01-12	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)
Precision AI Surgical Planning System (PAI-SPS) Precision AI Pty, Ltd. Cleared 2026-01-12 Registered with US (FDA)	Precision AI Pty, Ltd.	2026-01-12	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)
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) Foshan Topmed Dental Co., Ltd. Cleared 2026-01-12 Registered with US (FDA)	Foshan Topmed Dental Co., Ltd.	2026-01-12	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 Surgical Face Mask (3P00B, C2900) Beatles Medical Supplies (Xiantao) Co., Ltd. Cleared 2026-01-12 Registered with US (FDA)	Beatles Medical Supplies (Xiantao) Co., Ltd.	2026-01-12	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)
Star E900 Electric System DENTALEZ, INC., STARDENTAL DIVISION Cleared 2026-01-12 Registered with US (FDA)	DENTALEZ, INC., STARDENTAL DIVISION	2026-01-12	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)
DYNAMIS™ Navigation System Promethean Restorative, LLC Cleared 2026-01-12 Registered with US (FDA)	Promethean Restorative, LLC	2026-01-12	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)
SafeOp 3: Neural Informatix System Alphatec Spine, Inc. Cleared 2026-01-11 Registered with US (FDA) AU (TGA)	Alphatec Spine, Inc.	2026-01-11	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) Ningbo Ranor Medical Technology Co., Ltd. Cleared 2026-01-09 Registered with US (FDA)	Ningbo Ranor Medical Technology Co., Ltd.	2026-01-09	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 Neonatal NIBP Cuff (U1681S-C51N) Unimed Medical Supplies, Inc. Cleared 2026-01-09 Registered with US (FDA)	Unimed Medical Supplies, Inc.	2026-01-09	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)
NextAR Hip Platform Medacta International S.A. Cleared 2026-01-09 Registered with US (FDA)	Medacta International S.A.	2026-01-09	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)
Solo Pace Fusion System (SOLOFUSE1) Solo Pace, Inc. Cleared 2026-01-09 Registered with US (FDA)	Solo Pace, Inc.	2026-01-09	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)
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series Liaoning Upcera Co., Ltd. Cleared 2026-01-09 Registered with US (FDA)	Liaoning Upcera Co., Ltd.	2026-01-09	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)
Self-Forming Magnet (Flexagon Plus OTOLoc) Gi Windows, Inc. Cleared 2026-01-09 Registered with US (FDA)	Gi Windows, Inc.	2026-01-09	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)
ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) Ethicon Endo-Surgery, Inc. Cleared 2026-01-09 Registered with US (FDA) AU (TGA)	Ethicon Endo-Surgery, Inc.	2026-01-09	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Corvair Monza AliveCor, Inc. Cleared 2026-01-09 Registered with US (FDA)	AliveCor, Inc.	2026-01-09	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)
Nova Allegro UACR Assay, Nova Allegro Analyzer Nova Biomedical Corp. Cleared 2026-01-09 Registered with US (FDA)	Nova Biomedical Corp.	2026-01-09	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)
Core Metabolic Truvian Health Cleared 2026-01-09 Registered with US (FDA)	Truvian Health	2026-01-09	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)
JARVIS Metaphyseal Stem FH INDUSTRIE Cleared 2026-01-09 Registered with US (FDA)	FH INDUSTRIE	2026-01-09	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)
iotaSOFT® Insertion System Iotamotion, Inc. Cleared 2026-01-09 Registered with US (FDA)	Iotamotion, Inc.	2026-01-09	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)
KabiHelp® Uno; KabiHelp® Advance plus Fresenius Kabi AG Cleared 2026-01-09 Registered with US (FDA)	Fresenius Kabi AG	2026-01-09	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)
Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. Cleared 2026-01-09 Registered with US (FDA)	Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.	2026-01-09	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)
HemosIL Silica Clotting Time Instrumentation Laboratory (IL) Co. Cleared 2026-01-09 Registered with US (FDA)	Instrumentation Laboratory (IL) Co.	2026-01-09	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)
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) Shenzhen Med-link Electronics Tech Co,LTD Cleared 2026-01-08 Registered with US (FDA)	Shenzhen Med-link Electronics Tech Co,LTD	2026-01-08	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)
S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System Cordis US Corp Cleared 2026-01-08 Registered with US (FDA)	Cordis US Corp	2026-01-08	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)
Titanium Interbody System Spine Innovation, LLC Cleared 2026-01-08 Registered with US (FDA)	Spine Innovation, LLC	2026-01-08	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)
Vision-MR™ Diagnostic Catheter Imricor Medical Systems, Inc. Cleared 2026-01-08 Registered with US (FDA)	Imricor Medical Systems, Inc.	2026-01-08	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)
Advantage-C™ Ti3D Cervical Interbody Fusion Device Intelivation Technologies Cleared 2026-01-08 Registered with US (FDA)	Intelivation Technologies	2026-01-08	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)
View Ge Healthcare Cleared 2026-01-08 Registered with US (FDA)	Ge Healthcare	2026-01-08	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)
revyve® Antimicrobial Skin and Wound Cleanser Kane Biotech, Inc. Cleared 2026-01-08 Registered with US (FDA)	Kane Biotech, Inc.	2026-01-08	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 Totus GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Cleared 2026-01-08 Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	2026-01-08	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)
ENROUTE TRANSCAROTID STENT SYSTEM Boston Scientific Corp Cleared 2026-01-08 Registered with US (FDA)	Boston Scientific Corp	2026-01-08	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)
ZENEX Implant System_R-System Izenimplant Co.,Ltd Cleared 2026-01-08 Registered with US (FDA)	Izenimplant Co.,Ltd	2026-01-08	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)
Fetal Doppler U8-25, U9-25 Zhongshan Xiaolan Town Senlan Electronic Factory Cleared 2026-01-08 Registered with US (FDA)	Zhongshan Xiaolan Town Senlan Electronic Factory	2026-01-08	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)
S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent System; S.M.A.R.T. RADIANZ™ Vascular Stent System Cordis US Corp Cleared 2026-01-08 Registered with US (FDA)	Cordis US Corp	2026-01-08	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)
3DICOM MD Cloud Singular Health Pty, Ltd. Cleared 2026-01-08 Registered with US (FDA)	Singular Health Pty, Ltd.	2026-01-08	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)
EXOSEAL® Vascular Closure Device Cordis US Corp Cleared 2026-01-08 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Cordis US Corp	2026-01-08	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) Tornier, Inc Cleared 2026-01-08 Registered with US (FDA)	Tornier, Inc	2026-01-08	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)
MiniMed Go App Medtronic Minimed Cleared 2026-01-08 Registered with US (FDA) UK (MHRA)	Medtronic Minimed	2026-01-08	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) Shenzhen Best Electronics Co.,Ltd Cleared 2026-01-07 Registered with US (FDA)	Shenzhen Best Electronics Co.,Ltd	2026-01-07	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)
SmileInspector Amv Consulting, LLC Cleared 2026-01-07 Registered with US (FDA)	Amv Consulting, LLC	2026-01-07	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)
DS Core Detect Dentsply Sirona Cleared 2026-01-07 Registered with US (FDA)	Dentsply Sirona	2026-01-07	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)
LimFlow System LimFlow, Inc. Cleared 2026-01-07 Registered with US (FDA)	LimFlow, Inc.	2026-01-07	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)