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
Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent Edwards Lifesciences, LLC Cleared 2026-06-04 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Edwards Lifesciences, LLC	2026-06-04	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Dental Cone Beam Computed Tomography System Yofo Medical Technology Co., Ltd. Cleared 2026-06-04 Registered with US (FDA)	Yofo Medical Technology Co., Ltd.	2026-06-04	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)
Agili-C Smith & Nephew, Inc. Cleared 2026-06-04 Registered with US (FDA)	Smith & Nephew, Inc.	2026-06-04	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)
Respiratory Gating for Scanners (2.1) Varian Medical Systems inc Cleared 2026-06-04 Registered with US (FDA)	Varian Medical Systems inc	2026-06-04	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)
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar Fo Integra Lifesciences Corp. Cleared 2026-06-04 Registered with US (FDA)	Integra Lifesciences Corp.	2026-06-04	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)
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) GT METABOLIC SOLUTIONS, INC. Cleared 2026-06-04 Registered with US (FDA)	GT METABOLIC SOLUTIONS, INC.	2026-06-04	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)
TheraSphere™ Y-90 Glass Microspheres System Boston Scientific Corp Cleared 2026-06-04 Registered with US (FDA)	Boston Scientific Corp	2026-06-04	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)
Micra™ Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS Medtronic, Inc Cleared 2026-06-04 Registered with US (FDA)	Medtronic, Inc	2026-06-04	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)
Spectra Platinum Mini Uzinmedicare Co. Cleared 2026-06-04 Registered with US (FDA)	Uzinmedicare Co.	2026-06-04	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)
Strauss Surgical Resection Instruments AMERICAN MEDICAL ENDOSCOPY, INC. Cleared 2026-06-04 Registered with US (FDA)	AMERICAN MEDICAL ENDOSCOPY, INC.	2026-06-04	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)
Orion ResMed PTY Ltd Cleared 2026-06-04 Registered with US (FDA)	ResMed PTY Ltd	2026-06-04	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)
Harmony Referral System with Harmony OCT Viewer (Octave) Topcon Healthcare Solutions EMEA Oy Cleared 2026-06-04 Registered with US (FDA)	Topcon Healthcare Solutions EMEA Oy	2026-06-04	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)
LumiGlam Laser System (SHE-LSP601-3) Beijing Sano Laser S&T Development Co.,Ltd Cleared 2026-06-04 Registered with US (FDA)	Beijing Sano Laser S&T Development Co.,Ltd	2026-06-04	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)
LUNA 3D LAP GmbH Laser Applikationen Cleared 2026-06-04 Registered with US (FDA) UK (MHRA)	LAP GmbH Laser Applikationen	2026-06-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX DiaSorin, Inc. Cleared 2026-06-04 Registered with US (FDA)	DiaSorin, Inc.	2026-06-04	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)
Sonio Suspect Sonio Cleared 2026-06-04 Registered with US (FDA) EU (EUDAMED)	Sonio	2026-06-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) New York Embroidery Studio (NYES) Cleared 2026-06-04 Registered with US (FDA)	New York Embroidery Studio (NYES)	2026-06-04	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)
Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas) Cleared 2026-06-04 Registered with US (FDA)	Orthosoft Inc (D/B/A Zimmer Cas)	2026-06-04	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)
BOND ORACLE HER2 IHC SYSTEM Leica Biosystems Cleared 2026-06-04 Registered with US (FDA)	Leica Biosystems	2026-06-04	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)
DEEPVESSEL Plaque Keya Medical Technology Co., Ltd. Cleared 2026-06-04 Registered with US (FDA)	Keya Medical Technology Co., Ltd.	2026-06-04	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)
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent - Fibrillar Form Integra Lifesciences Corp. Cleared 2026-06-04 Registered with US (FDA)	Integra Lifesciences Corp.	2026-06-04	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)
Optune Gio Novocure, GmbH Cleared 2026-06-04 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Novocure, GmbH	2026-06-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Radius VSM and Accessories Masimo Corp. Cleared 2026-06-04 Registered with US (FDA) AU (TGA)	Masimo Corp.	2026-06-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
TroKit Laparoscope Lens Wiper TroCare, LLC Cleared 2026-06-04 Registered with US (FDA)	TroCare, LLC	2026-06-04	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)
MeRT System Wave Neuroscience Cleared 2026-06-03 Registered with US (FDA)	Wave Neuroscience	2026-06-03	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)
Alto Abdominal Stent Graft System Endologix, Inc. Cleared 2026-06-03 Registered with US (FDA)	Endologix, Inc.	2026-06-03	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)
BioWave BioWraps Biowave Corporation Cleared 2026-06-03 Registered with US (FDA) AU (TGA)	Biowave Corporation	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Permatage Flowable, Settable Hemostatic Bone Paste Orthocon, LLC Cleared 2026-06-03 Registered with US (FDA)	Orthocon, LLC	2026-06-03	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)
INSPIRIS RESILIA Aortic Valve Edwards Lifesciences, LLC Cleared 2026-06-03 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Edwards Lifesciences, LLC	2026-06-03	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
SteriTite Container System with MediTray Products Case Medical, Inc. Cleared 2026-06-03 Registered with US (FDA)	Case Medical, Inc.	2026-06-03	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)
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl S&S Glove Corporation Cleared 2026-06-03 Registered with US (FDA)	S&S Glove Corporation	2026-06-03	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)
SIC Abutments including CAD/CAM Solutions SIC invent AG Cleared 2026-06-03 Registered with US (FDA)	SIC invent AG	2026-06-03	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)
BracePaste Prime Plus American Orthodontics Cleared 2026-06-03 Registered with US (FDA) Canada (Health Canada)	American Orthodontics	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
iiSure Infusion Set Deka Research & Development Corp. Cleared 2026-06-03 Registered with US (FDA)	Deka Research & Development Corp.	2026-06-03	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)
Electric Wheelchair (DF506) Jiangsu Yveelt Medical Equipment Co., Ltd. Cleared 2026-06-03 Registered with US (FDA)	Jiangsu Yveelt Medical Equipment Co., Ltd.	2026-06-03	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)
EMBLEM, EMBLEM MRI Boston Scientific Corp Cleared 2026-06-03 Registered with US (FDA)	Boston Scientific Corp	2026-06-03	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)
Tissue Approximation System Tas Medical, Inc. Cleared 2026-06-03 Registered with US (FDA)	Tas Medical, Inc.	2026-06-03	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)
Roosin Collagen Powder Roosin Medical Co, Ltd Cleared 2026-06-03 Registered with US (FDA)	Roosin Medical Co, Ltd	2026-06-03	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)
KARL STORZ Endoscopic Accessories for Urology Karl Storz SE & CO.KG Cleared 2026-06-03 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-06-03	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)
HeartFocus Deski Cleared 2026-06-03 Registered with US (FDA)	Deski	2026-06-03	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)
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Edwards Lifesciences, LLC Cleared 2026-06-03 Registered with US (FDA)	Edwards Lifesciences, LLC	2026-06-03	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)
Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar Edwards Lifesciences, LLC Cleared 2026-06-03 Registered with US (FDA)	Edwards Lifesciences, LLC	2026-06-03	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)
Esteem System Envoy Medical Corporation Cleared 2026-06-03 Registered with US (FDA)	Envoy Medical Corporation	2026-06-03	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)
LCS TOTAL KNEE SYSTEM Depuy, Inc. Cleared 2026-06-03 Registered with US (FDA)	Depuy, Inc.	2026-06-03	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)
SENSAR™ 3-Piece Monofocal IOL, Models, AR40e, AR40E, AR40M, AR40MN Johnson&Johnson Surgical Vision Inc Cleared 2026-06-03 Registered with US (FDA) AU (TGA)	Johnson&Johnson Surgical Vision Inc	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480 Boston Scientific Corp Cleared 2026-06-03 Registered with US (FDA)	Boston Scientific Corp	2026-06-03	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)
VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 Guidant Corp. Cleared 2026-06-03 Registered with US (FDA)	Guidant Corp.	2026-06-03	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)
INOGEN, DYNAGEN, MOMENTUM, VIGILANT EL, PERCIVA MINI, RESONATE EL, PERCIVA HF, RESONATE HF Boston Scientific Corp Cleared 2026-06-03 Registered with US (FDA)	Boston Scientific Corp	2026-06-03	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)
TECNIS™ 3-Piece Multifocal, Model ZMA00 Johnson&Johnson Surgical Vision Inc Cleared 2026-06-03 Registered with US (FDA)	Johnson&Johnson Surgical Vision Inc	2026-06-03	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)
CustoMED Viewer Customed, Inc. Cleared 2026-06-03 Registered with US (FDA) EU (EUDAMED)	Customed, Inc.	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)