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.

3,686 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
Etema™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Abbott Medical Cleared 2026-08-07 Registered with US (FDA)	Abbott Medical	2026-08-07	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)
THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER Abbott Medical Cleared 2026-08-07 Registered with US (FDA)	Abbott Medical	2026-08-07	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)
mdprostate mediaire GmbH Cleared 2026-08-07 Registered with US (FDA) UK (MHRA)	mediaire GmbH	2026-08-07	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Orsiro Mission larger diameter stents Ø 4.5 5.0 mm Biotronik, GmbH & Co. Cleared 2026-08-07 Registered with US (FDA)	Biotronik, GmbH & Co.	2026-08-07	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)
Mistral-Air® Warming System THE SURGICAL COMPANY INTERNATIONAL B.V. DOING BUSINESS AS TSC LIFE Cleared 2026-08-07 Registered with US (FDA)	THE SURGICAL COMPANY INTERNATIONAL B.V. DOING BUSINESS AS TSC LIFE	2026-08-07	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)
Ampere™ Generator Irvine Biomedical, Inc. Cleared 2026-08-07 Registered with US (FDA)	Irvine Biomedical, Inc.	2026-08-07	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)
TactiFlex™ Ablation Catheter, Sensor Enabled™ Abbott Medical Cleared 2026-08-07 Registered with US (FDA) Canada (Health Canada)	Abbott Medical	2026-08-07	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Arthrex Bioabsorbable PushLock Suture Anchors Arthrex, Inc. Cleared 2026-08-07 Registered with US (FDA)	Arthrex, Inc.	2026-08-07	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)
Aperio GT 450 DX; Aperio GT 180 DX Leica Biosystems Imaging, Inc. Cleared 2026-08-07 Registered with US (FDA)	Leica Biosystems Imaging, Inc.	2026-08-07	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)
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) Shenzhen Chuangtong Yigou Technology Co., Ltd. Cleared 2026-08-07 Registered with US (FDA)	Shenzhen Chuangtong Yigou Technology Co., Ltd.	2026-08-07	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)
Intuitive Endoluminal Gastrointestinal System (IG1000) Intuitive Surgical, Inc. Cleared 2026-08-07 Registered with US (FDA)	Intuitive Surgical, Inc.	2026-08-07	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)
Bellafill Dermal Filler TIGER AESTHETICS MEDICAL, LLC Cleared 2026-08-07 Registered with US (FDA)	TIGER AESTHETICS MEDICAL, LLC	2026-08-07	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)
Guardant360 CDx Guardant Health, Inc. Cleared 2026-08-07 Registered with US (FDA) UK (MHRA)	Guardant Health, Inc.	2026-08-07	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) YADU Medical (Henan) Co, Ltd Cleared 2026-08-07 Registered with US (FDA)	YADU Medical (Henan) Co, Ltd	2026-08-07	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)
THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS Irvine Biomedical,Inc.(Ibi) Cleared 2026-08-07 Registered with US (FDA)	Irvine Biomedical,Inc.(Ibi)	2026-08-07	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)
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ St. Jude Medical, Inc. Cleared 2026-08-07 Registered with US (FDA)	St. Jude Medical, Inc.	2026-08-07	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)
Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Cleared 2026-08-07 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	2026-08-07	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
BUM Oil Bumlicious, LLC (DBA "Bumlicious") Cleared 2026-08-07 Registered with US (FDA)	Bumlicious, LLC (DBA "Bumlicious")	2026-08-07	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)
PerClot® Polysaccharide Hemostatic System Baxter Healthcare Corp Cleared 2026-08-07 Registered with US (FDA)	Baxter Healthcare Corp	2026-08-07	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)
Axonics Sacral Neuromodulation (SNM) System Boston Scientific Corp Cleared 2026-08-07 Registered with US (FDA)	Boston Scientific Corp	2026-08-07	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)
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) Lakong Medical Devices Co., Ltd. Cleared 2026-08-07 Registered with US (FDA)	Lakong Medical Devices Co., Ltd.	2026-08-07	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)
Freedom Total Knee System (E-Poly Tibial Liners) Maxx Orthopedics, Inc. Cleared 2026-08-07 Registered with US (FDA)	Maxx Orthopedics, Inc.	2026-08-07	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)
OrganOx metra System Organox Limited Cleared 2026-08-07 Registered with US (FDA)	Organox Limited	2026-08-07	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)
QIAstat-Dx BCID GPF Plus AMR Panel QIAGEN GmbH Cleared 2026-08-06 Registered with US (FDA) EU (EUDAMED)	QIAGEN GmbH	2026-08-06	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Aristotle Mini Guidewire Scientia Vascular, LLC Cleared 2026-08-06 Registered with US (FDA)	Scientia Vascular, LLC	2026-08-06	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)
Manual Wheelchair (H008, PCK7) Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. Cleared 2026-08-06 Registered with US (FDA)	Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.	2026-08-06	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)
Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw Nobel Biocare AB Cleared 2026-08-06 Registered with US (FDA)	Nobel Biocare AB	2026-08-06	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)
Telemetry Monitor (iT30, iT50) Edan Instruments, Inc Cleared 2026-08-06 Registered with US (FDA)	Edan Instruments, Inc	2026-08-06	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)
HexaGen RF Generator Software and Remote Medtronic, Inc Cleared 2026-08-06 Registered with US (FDA) UK (MHRA)	Medtronic, Inc	2026-08-06	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Overjet Multi-Image Caries and Charting Assist Overjet, Inc. Cleared 2026-08-06 Registered with US (FDA)	Overjet, Inc.	2026-08-06	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)
EluNIR™ Ridaforolimus Eluting Coronary Stent System Medinol , Ltd. Cleared 2026-08-06 Registered with US (FDA)	Medinol , Ltd.	2026-08-06	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)
Megalodon Dynamic Compression System Paragon 28, Inc Cleared 2026-08-06 Registered with US (FDA)	Paragon 28, Inc	2026-08-06	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)
Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) Mozarc Medical US LLc Cleared 2026-08-06 Registered with US (FDA)	Mozarc Medical US LLc	2026-08-06	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)
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System Howmedica Osteonics Corp., Dba Stryker Orthopaedics Cleared 2026-08-06 Registered with US (FDA)	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2026-08-06	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)
ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER Medtronic Cryocath, LP Cleared 2026-08-06 Registered with US (FDA)	Medtronic Cryocath, LP	2026-08-06	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)
EVOQUE Tricuspid Delivery System (9850TDS); EVOQUE dilator kit (9850DK) Edwards Lifesciences, LLC Cleared 2026-08-05 Registered with US (FDA) AU (TGA)	Edwards Lifesciences, LLC	2026-08-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
NaturaJel™ Oral Wound Care Kit HCS Innovation, LLC Cleared 2026-08-05 Registered with US (FDA)	HCS Innovation, LLC	2026-08-05	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)
GFS - Sterile Screws and Top Hat Tag Medical Products Cleared 2026-08-05 Registered with US (FDA)	Tag Medical Products	2026-08-05	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)
Belotero® Intense (+) Lidocaine Merz North America, Inc. Cleared 2026-08-05 Registered with US (FDA)	Merz North America, Inc.	2026-08-05	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)
Transurethral Catheter Safety Valve (TUCSV) (80050) Class Medical Ltd Cleared 2026-08-05 Registered with US (FDA)	Class Medical Ltd	2026-08-05	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)
Huahong Sharps Container (HHR-I, HHR-II) Tianjin Huahong Technology Co, Ltd Cleared 2026-08-05 Registered with US (FDA)	Tianjin Huahong Technology Co, Ltd	2026-08-05	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)
DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens Tianjin Mastervision Technology Co., Ltd. Cleared 2026-08-05 Registered with US (FDA)	Tianjin Mastervision Technology Co., Ltd.	2026-08-05	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)
pVasc Net Mechanical Thrombectomy Device Vesalio Cleared 2026-08-05 Registered with US (FDA)	Vesalio	2026-08-05	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)
CAD - Lower GI (EC07-01) Xiamen Inno Medical Technology Co., Ltd. Cleared 2026-08-05 Registered with US (FDA)	Xiamen Inno Medical Technology Co., Ltd.	2026-08-05	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)
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)
HeartWare™ Ventricular Assist System or HeartWare™ System Medtronic, Inc Cleared 2026-08-05 Registered with US (FDA)	Medtronic, Inc	2026-08-05	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)
Onyx™ Liquid Embolic System (LES) Ev3 Neurovascular Cleared 2026-08-05 Registered with US (FDA)	Ev3 Neurovascular	2026-08-05	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)
RUTHINIUM DISC Dental Manufacturing S.P.A Cleared 2026-08-05 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Dental Manufacturing S.P.A	2026-08-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). ConvaTec Limited Cleared 2026-08-05 Registered with US (FDA)	ConvaTec Limited	2026-08-05	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)
Leksell® Vantage Stereotactic System Elekta Solutions AB Cleared 2026-08-05 Registered with US (FDA) AU (TGA)	Elekta Solutions AB	2026-08-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)