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.

3,716 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
Concentriq AP-Dx Proscia, Inc Cleared 2026-08-05 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Proscia, Inc	2026-08-05	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
OMNI Ultra Surgical System (1-110) Sight Sciences, Inc. Cleared 2026-08-04 Registered with US (FDA)	Sight Sciences, Inc.	2026-08-04	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)
Vertex™ Thrombectomy System Jupiter Endovascular Cleared 2026-08-04 Registered with US (FDA)	Jupiter Endovascular	2026-08-04	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)
LED Light Therapy Masks (PE748, PE749, PE756) Duplex International Trading Limited Cleared 2026-08-04 Registered with US (FDA)	Duplex International Trading Limited	2026-08-04	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)
LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) Shenzhen Qianyu Technology Co., Ltd. Cleared 2026-08-04 Registered with US (FDA)	Shenzhen Qianyu Technology Co., Ltd.	2026-08-04	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)
On-X Prosthetic Heart Valve On-X Life Technologies, Inc. Cleared 2026-08-04 Registered with US (FDA) EU (EUDAMED)	On-X Life Technologies, Inc.	2026-08-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Ranger™ Paclitaxel-Coated PTA Balloon Catheter Boston Scientific Corp Cleared 2026-08-04 Registered with US (FDA) UK (MHRA) AU (TGA)	Boston Scientific Corp	2026-08-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
ANGIO-SEAL VIP Vascular Closure Device Terumo Medical Corp. Cleared 2026-08-04 Registered with US (FDA) AU (TGA)	Terumo Medical Corp.	2026-08-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Alturion Series Diagnostic Ultrasound System Philips Ultrasound, Inc. Cleared 2026-08-04 Registered with US (FDA)	Philips Ultrasound, Inc.	2026-08-04	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)
RealGUIDE 3DIEMME Srl Cleared 2026-08-04 Registered with US (FDA) EU (EUDAMED)	3DIEMME Srl	2026-08-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Zenith Fenestrated AAA Endovascular Graft William Cook Europe Aps Cleared 2026-08-04 Registered with US (FDA)	William Cook Europe Aps	2026-08-04	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)
TRIVANCE™ Hip Stem Globus Medical, Inc. Cleared 2026-08-04 Registered with US (FDA)	Globus Medical, Inc.	2026-08-04	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)
Freedom Partial Knee System Maxx Orthopedics, Inc. Cleared 2026-08-04 Registered with US (FDA)	Maxx Orthopedics, Inc.	2026-08-04	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)
Navigator™ Flex Ureteral Access Sheath Set Boston Scientific Corp Cleared 2026-08-04 Registered with US (FDA)	Boston Scientific Corp	2026-08-04	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)
Zenith Alpha Thoracic Endovascular Graft; Zenith Dissection Endovascular System Cook, Medical Cleared 2026-08-04 Registered with US (FDA)	Cook, Medical	2026-08-04	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)
Marrow Marxman Medimetrix, LLC Cleared 2026-08-04 Registered with US (FDA)	Medimetrix, LLC	2026-08-04	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)
VueJect® Ultrasound Enhancing Agent Delivery System Acist Medical Systems Cleared 2026-08-03 Registered with US (FDA) Canada (Health Canada)	Acist Medical Systems	2026-08-03	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Grappler Suture Anchor System Paragon 28, Inc Cleared 2026-08-03 Registered with US (FDA) AU (TGA)	Paragon 28, Inc	2026-08-03	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
GORE HELIX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2090, HX2095 W. L. Gore and Associates, Inc. Cleared 2026-08-03 Registered with US (FDA) UK (MHRA) AU (TGA)	W. L. Gore and Associates, Inc.	2026-08-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Halcyon, Ethos Radiotherapy System (5.0) Varian Medical Systems inc Cleared 2026-08-03 Registered with US (FDA)	Varian Medical Systems inc	2026-08-03	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)
PuraStat-RM 3-D Matrix, Inc. Cleared 2026-08-03 Registered with US (FDA)	3-D Matrix, Inc.	2026-08-03	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)
GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX) Lynch Biologics, LLC Cleared 2026-08-03 Registered with US (FDA)	Lynch Biologics, LLC	2026-08-03	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)
PuraStat-GI 3-D Matrix, Inc. Cleared 2026-08-03 Registered with US (FDA)	3-D Matrix, Inc.	2026-08-03	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)
Eve Wandercraft Sas Cleared 2026-08-03 Registered with US (FDA)	Wandercraft Sas	2026-08-03	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)
Cologuard Plus™ Exact Sciences Corporation Cleared 2026-08-03 Registered with US (FDA)	Exact Sciences Corporation	2026-08-03	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)
SABER-XA System Elevation Spine Cleared 2026-08-03 Registered with US (FDA)	Elevation Spine	2026-08-03	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)
XLITE Gemss Healthcare Co., Ltd. Cleared 2026-08-03 Registered with US (FDA)	Gemss Healthcare Co., Ltd.	2026-08-03	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)
Affinity Hermes Medical Solutions AB Cleared 2026-07-31 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Hermes Medical Solutions AB	2026-07-31	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
I-Genius (100019400) Esaote, S.P.A. Cleared 2026-07-31 Registered with US (FDA)	Esaote, S.P.A.	2026-07-31	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)
Hearing Aid Feature Samsung Electronics Co., Ltd. Cleared 2026-07-31 Registered with US (FDA)	Samsung Electronics Co., Ltd.	2026-07-31	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)
SnØreNegatØr DnB Innovations, LLC Cleared 2026-07-31 Registered with US (FDA)	DnB Innovations, LLC	2026-07-31	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)
Shield System (Siemens 30x40) Radiaction , Ltd. Cleared 2026-07-31 Registered with US (FDA)	Radiaction , Ltd.	2026-07-31	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)
CareLink SmartSync Device Manager Base (24970A) Medtronic, Inc Cleared 2026-07-31 Registered with US (FDA)	Medtronic, Inc	2026-07-31	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)
Aurora EV-ICD (DVEA3E4) Medtronic, Inc Cleared 2026-07-31 Registered with US (FDA) AU (TGA)	Medtronic, Inc	2026-07-31	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) Olympus Medical Systems Corporation Cleared 2026-07-31 Registered with US (FDA)	Olympus Medical Systems Corporation	2026-07-31	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)
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) Globus Medical, Inc. Cleared 2026-07-31 Registered with US (FDA)	Globus Medical, Inc.	2026-07-31	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)
RadioViewAI Neurocareai, Inc. (Dba Savelife.Ai) Cleared 2026-07-31 Registered with US (FDA)	Neurocareai, Inc. (Dba Savelife.Ai)	2026-07-31	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)
Flexitouch® Plus Advanced Pneumatic Compression System Tactile Medical Cleared 2026-07-31 Registered with US (FDA)	Tactile Medical	2026-07-31	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)
WatchPAT SW Itamar Medical Cleared 2026-07-31 Registered with US (FDA)	Itamar Medical	2026-07-31	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)
xvision Spine System Augmedics, Ltd. Cleared 2026-07-31 Registered with US (FDA)	Augmedics, Ltd.	2026-07-31	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)
MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure Siemens Healthineers AG Cleared 2026-07-31 Registered with US (FDA)	Siemens Healthineers AG	2026-07-31	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)
LightStim for Wrinkles (1984); LightStim for Acne (2038) Led Intellectual Properties, LLC Cleared 2026-07-31 Registered with US (FDA)	Led Intellectual Properties, LLC	2026-07-31	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)
UniPearls® Embolic Microspheres Suzhou Haowei Medical Technology Co., Ltd. Cleared 2026-07-31 Registered with US (FDA)	Suzhou Haowei Medical Technology Co., Ltd.	2026-07-31	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)
0909FCE, 0909FCE-HS Rayence Co., Ltd. Cleared 2026-07-31 Registered with US (FDA)	Rayence Co., Ltd.	2026-07-31	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)
Vertiwedge® Intraosseous System Foundation Surgical Group, Inc. Cleared 2026-07-31 Registered with US (FDA)	Foundation Surgical Group, Inc.	2026-07-31	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)
Interwedge® Standalone Lateral Foundation Surgical Group, Inc. Cleared 2026-07-31 Registered with US (FDA)	Foundation Surgical Group, Inc.	2026-07-31	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)
VitalFlow Set with Balance Biosurface Medtronic, Inc Cleared 2026-07-31 Registered with US (FDA)	Medtronic, Inc	2026-07-31	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)
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) OrthAlign, Inc Cleared 2026-07-31 Registered with US (FDA)	OrthAlign, Inc	2026-07-31	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)
MAGiC Ablation Catheter Stereotaxis, Inc. Cleared 2026-07-31 Registered with US (FDA)	Stereotaxis, Inc.	2026-07-31	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)
Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) Shanghai Hulu Devices Co., Ltd. Cleared 2026-07-31 Registered with US (FDA)	Shanghai Hulu Devices Co., Ltd.	2026-07-31	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)