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.

3,689 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
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)
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)
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)
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)
PuraStat 3-D MATRIX EUROPE SAS Cleared 2026-01-07 Registered with US (FDA) Canada (Health Canada) AU (TGA)	3-D MATRIX EUROPE SAS	2026-01-07	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) MEDTRONIC SOFAMOR DANEK USA, INC. Cleared 2026-01-07 Registered with US (FDA)	MEDTRONIC SOFAMOR DANEK USA, 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)
Clear Aligner (SCF-3348) Beame Medical Technology (Shenzhen) Limited Cleared 2026-01-07 Registered with US (FDA)	Beame Medical Technology (Shenzhen) Limited	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)
VyBrate™ VBR System Vy Spine, LLC Cleared 2026-01-07 Registered with US (FDA)	Vy Spine, 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)
Sangria™ Thrombectomy System Avantec Vascular Corp. Cleared 2026-01-07 Registered with US (FDA)	Avantec Vascular Corp.	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)
Neodent InLab Validated Workflow Jjgc Industria E Comercio DE Materiais Dentarios S.A. Cleared 2026-01-07 Registered with US (FDA)	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	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)
ZenSeal Pro KERR CORPORATION Cleared 2026-01-07 Registered with US (FDA)	KERR CORPORATION	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)
BriefCase-Triage: CARE Multi-triage CT Body Aidoc Medical , Ltd. Cleared 2026-01-07 Registered with US (FDA)	Aidoc Medical , 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)
DeltaWave Nasal Pillow System Remsleep Holdings Cleared 2026-01-07 Registered with US (FDA)	Remsleep Holdings	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)
Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC Cleared 2026-01-07 Registered with US (FDA)	Innovative Health, 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)
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models Materialise N.V Cleared 2026-01-07 Registered with US (FDA)	Materialise N.V	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)
LOGIQ Fortis GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Cleared 2026-01-07 Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, 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)
aprevo® cervical interbody system Carlsmed, Inc. Cleared 2026-01-06 Registered with US (FDA)	Carlsmed, Inc.	2026-01-06	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)
Pen Needle Hh Global Technology, Inc. Cleared 2026-01-06 Registered with US (FDA)	Hh Global Technology, Inc.	2026-01-06	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)
Sensilift Pro (ST300XXYYZZZ) El Global Trade, Ltd. Cleared 2026-01-06 Registered with US (FDA)	El Global Trade, Ltd.	2026-01-06	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)
Saans (F4-01-00-000-000) Innaccel Technologies Private Limited Cleared 2026-01-06 Registered with US (FDA)	Innaccel Technologies Private Limited	2026-01-06	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)
Materialise TKA Guide System Materialise N.V Cleared 2026-01-06 Registered with US (FDA)	Materialise N.V	2026-01-06	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)
QuadLock™ Fixation System ABANZA TECNOMED, S.L. Cleared 2026-01-06 Registered with US (FDA)	ABANZA TECNOMED, S.L.	2026-01-06	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)
TriLEAP Plating System Crossroads Extremity Systems, LLC Cleared 2026-01-06 Registered with US (FDA)	Crossroads Extremity Systems, LLC	2026-01-06	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)
V-DAC Catheter Vesalio Cleared 2026-01-06 Registered with US (FDA)	Vesalio	2026-01-06	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)
Medconn 8K Glycated Hemoglobin Test System Shanghai Medconn Medical Technology Co.,Ltd. Cleared 2026-01-06 Registered with US (FDA)	Shanghai Medconn Medical Technology Co.,Ltd.	2026-01-06	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)
maiLink Maihub Corp. Cleared 2026-01-05 Registered with US (FDA)	Maihub Corp.	2026-01-05	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)
SurfRider 13 Microcatheter Kaneka Americas Holding, Inc. Cleared 2026-01-05 Registered with US (FDA)	Kaneka Americas Holding, Inc.	2026-01-05	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)
ORBERA Intragastric Balloon System Boston Scientific Corp Cleared 2026-01-05 Registered with US (FDA)	Boston Scientific Corp	2026-01-05	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 Medical Face Mask Makrite Industries, Inc. Cleared 2026-01-05 Registered with US (FDA) EU (EUDAMED)	Makrite Industries, Inc.	2026-01-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Puracyn® Plus Antimicrobial Irrigation Solution INNOVACYN, INC. Cleared 2026-01-05 Registered with US (FDA)	INNOVACYN, INC.	2026-01-05	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)