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
Augmented Gingival Matrix Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. Cleared 2025-12-05 Registered with US (FDA)	Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.	2025-12-05	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)
SpineLinc Anterior Cervical Implant System Lincotek Medical Cleared 2025-12-05 Registered with US (FDA)	Lincotek Medical	2025-12-05	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)
REAL INTELLIGENCE™ CORI™ XT (CORI XT) Blue Belt Technologies, Inc. Cleared 2025-12-05 Registered with US (FDA)	Blue Belt Technologies, Inc.	2025-12-05	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)
VSP Orthopedics System 3D Systems, Inc. Cleared 2025-12-05 Registered with US (FDA)	3D Systems, Inc.	2025-12-05	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)
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) Shenzhen Siken 3D Technology Development Co., Ltd. Cleared 2025-12-05 Registered with US (FDA)	Shenzhen Siken 3D Technology Development Co., Ltd.	2025-12-05	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)
ProSeal™ Transfer Injector (421120, 421130, 421140) Epic Medical Pte. , Ltd. Cleared 2025-12-05 Registered with US (FDA)	Epic Medical Pte. , Ltd.	2025-12-05	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)
ARTAssistant Manteia Technologies Co., Ltd. Cleared 2025-12-05 Registered with US (FDA) Canada (Health Canada)	Manteia Technologies Co., Ltd.	2025-12-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BLAZER OPEN-IRRIGATED ABLATION CATHETER Boston Scientific Corp Cleared 2025-12-05 Registered with US (FDA) UK (MHRA) AU (TGA)	Boston Scientific Corp	2025-12-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Manual Wheelchair (W45) Jiangsu Jumao X-Care Medical Equipment Co.,Ltd Cleared 2025-12-05 Registered with US (FDA)	Jiangsu Jumao X-Care Medical Equipment Co.,Ltd	2025-12-05	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)
PUREVUE™ FMS Novanta Medical GmbH Cleared 2025-12-05 Registered with US (FDA)	Novanta Medical GmbH	2025-12-05	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)
Remvia NightGuard Remvia Cleared 2025-12-05 Registered with US (FDA)	Remvia	2025-12-05	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)
MEMO Patch M (MPT-E08R-UNC01) HUINNO Co., Ltd. Cleared 2025-12-05 Registered with US (FDA)	HUINNO Co., Ltd.	2025-12-05	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)
Gastric Alimetry Alimetry , Ltd. Cleared 2025-12-05 Registered with US (FDA)	Alimetry , Ltd.	2025-12-05	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)
OncoPatch Oncopatch, Inc. Cleared 2025-12-05 Registered with US (FDA)	Oncopatch, Inc.	2025-12-05	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)
els unibond Saremco Dental AG Cleared 2025-12-05 Registered with US (FDA) UK (MHRA)	Saremco Dental AG	2025-12-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Electrically powered wheelchair (KZ301B) Nanjing Kangni Smart Technology Co., Ltd. Cleared 2025-12-05 Registered with US (FDA)	Nanjing Kangni Smart Technology Co., Ltd.	2025-12-05	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)
Overjet CBCT Assist Overjet, Inc. Cleared 2025-12-05 Registered with US (FDA)	Overjet, Inc.	2025-12-05	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)
QuietLab Pro QuietLab, LLC Cleared 2025-12-05 Registered with US (FDA)	QuietLab, LLC	2025-12-05	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)
Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) Sonoscape Medical Corp. Cleared 2025-12-05 Registered with US (FDA)	Sonoscape Medical Corp.	2025-12-05	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)
Velora Acetabular System Restor3d Cleared 2025-12-05 Registered with US (FDA)	Restor3d	2025-12-05	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)
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) Medspira, LLC Cleared 2025-12-05 Registered with US (FDA)	Medspira, LLC	2025-12-05	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)
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 Thermo Fisher Scientific (Oxoid Ltd.) Cleared 2025-12-05 Registered with US (FDA)	Thermo Fisher Scientific (Oxoid Ltd.)	2025-12-05	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)
ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses Bausch & Lomb Incorporated Cleared 2025-12-04 Registered with US (FDA)	Bausch & Lomb Incorporated	2025-12-04	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)
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] Np Medical, Inc. Cleared 2025-12-04 Registered with US (FDA)	Np Medical, Inc.	2025-12-04	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)
Tigon Medical Knotless and Dual Javelin All-Suture Anchors Tigon Medical Cleared 2025-12-04 Registered with US (FDA)	Tigon Medical	2025-12-04	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)
FFX Facet Fixation System SC MEDICA Cleared 2025-12-04 Registered with US (FDA)	SC MEDICA	2025-12-04	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 (T5) Zhejiang Taotao Vehicle Co., Ltd. Cleared 2025-12-04 Registered with US (FDA)	Zhejiang Taotao Vehicle Co., Ltd.	2025-12-04	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)
MitraPatch Mitral Valve Repair System Chawla Heart Technologies, LLC Cleared 2025-12-04 Registered with US (FDA)	Chawla Heart Technologies, LLC	2025-12-04	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)
Spineology Navigation Instruments Spineology, Inc. Cleared 2025-12-04 Registered with US (FDA)	Spineology, Inc.	2025-12-04	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)
ADVIA Centaur Anti-Thyroglobulin II (aTgII) Siemens Healthcare Diagnostics Cleared 2025-12-04 Registered with US (FDA)	Siemens Healthcare Diagnostics	2025-12-04	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)
Vektor Computational ECG Mapping System (vMap) Vektor Medical, Inc. Cleared 2025-12-04 Registered with US (FDA)	Vektor Medical, Inc.	2025-12-04	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)
ASUS Ultrasound Imaging System (LU800 series) Asustek Computer, Inc. Cleared 2025-12-04 Registered with US (FDA)	Asustek Computer, Inc.	2025-12-04	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)
Omnipod 5 algorithm Insulet Corp. Cleared 2025-12-03 Registered with US (FDA)	Insulet Corp.	2025-12-03	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)
Bendit17 Microcatheter Bend IT Technologies, Ltd. Cleared 2025-12-03 Registered with US (FDA)	Bend IT Technologies, Ltd.	2025-12-03	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)
Hugo™ RAS System Covidien Cleared 2025-12-03 Registered with US (FDA)	Covidien	2025-12-03	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)
GentleBeam (GB1000) Voxel Ray Solutions, LLC Cleared 2025-12-03 Registered with US (FDA)	Voxel Ray Solutions, LLC	2025-12-03	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)
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) YADU Medical (Henan) Co, Ltd Cleared 2025-12-03 Registered with US (FDA)	YADU Medical (Henan) Co, Ltd	2025-12-03	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)
AVIEW Lung Nodule CAD Coreline Soft Co.,Ltd Cleared 2025-12-03 Registered with US (FDA)	Coreline Soft Co.,Ltd	2025-12-03	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)
HippoMind (v1.0) Hippoclinic Cleared 2025-12-03 Registered with US (FDA)	Hippoclinic	2025-12-03	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)
VitaloJAK Clinic (Model 7100) VITALOGRAPH INC. Cleared 2025-12-03 Registered with US (FDA)	VITALOGRAPH INC.	2025-12-03	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)
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Cleared 2025-12-03 Registered with US (FDA)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2025-12-03	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 Endoscopic Injection Needles Changzhou New Med Micro-Medtech Co., Ltd. Cleared 2025-12-02 Registered with US (FDA)	Changzhou New Med Micro-Medtech Co., Ltd.	2025-12-02	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)
Aura Wave Aura Wellness, LLC Cleared 2025-12-02 Registered with US (FDA)	Aura Wellness, LLC	2025-12-02	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)
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe Becton Dickinson and Company Cleared 2025-12-02 Registered with US (FDA)	Becton Dickinson and Company	2025-12-02	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)
Minuteman® G6 MIS Fusion Plate SPINAL SIMPLICITY LLC Cleared 2025-12-01 Registered with US (FDA)	SPINAL SIMPLICITY LLC	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)
Led Light Phototherapy Bed (Pro 450/ GY-680A) Shenzhen Suyzeko Limited. Cleared 2025-12-01 Registered with US (FDA)	Shenzhen Suyzeko Limited.	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)
IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) Dragerwerk AG & Co KGaA Cleared 2025-12-01 Registered with US (FDA)	Dragerwerk AG & Co KGaA	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)
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) Unimed Medical Supplies, Inc. Cleared 2025-12-01 Registered with US (FDA)	Unimed Medical Supplies, Inc.	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)
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants Exactech, Inc. Cleared 2025-12-01 Registered with US (FDA)	Exactech, Inc.	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)
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) Unimed Medical Supplies, Inc. Cleared 2025-12-01 Registered with US (FDA)	Unimed Medical Supplies, Inc.	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)