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
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) Ram.Shaw Pte. , Ltd. Cleared 2026-03-03 Registered with US (FDA)	Ram.Shaw Pte. , Ltd.	2026-03-03	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)
Claire™ OCT System Perimeter Medical Imaging Ai, Inc. Cleared 2026-03-03 Registered with US (FDA)	Perimeter Medical Imaging Ai, Inc.	2026-03-03	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)
Bond-PR™ Universal Adhesive Premier Dental Products Co. Cleared 2026-03-03 Registered with US (FDA)	Premier Dental Products Co.	2026-03-03	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)
eCoin Tibial Nerve Stimulator System Boston Scientific Corp Cleared 2026-03-03 Registered with US (FDA)	Boston Scientific Corp	2026-03-03	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)
TMINI™ Miniature Robotic System THINK Surgical, Inc. Cleared 2026-03-03 Registered with US (FDA)	THINK Surgical, Inc.	2026-03-03	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)
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button Arthrex, Inc. Cleared 2026-03-03 Registered with US (FDA)	Arthrex, Inc.	2026-03-03	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)
Arthrex Nano FiberTak Suture Anchor Arthrex, Inc. Cleared 2026-03-02 Registered with US (FDA)	Arthrex, Inc.	2026-03-02	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)
MESI mTABLET SPIRO Mesi D.O.O. Cleared 2026-03-02 Registered with US (FDA)	Mesi D.O.O.	2026-03-02	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)
VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System SYNTHES GMBH Cleared 2026-03-02 Registered with US (FDA)	SYNTHES GMBH	2026-03-02	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)
KARL STORZ Mediastinoscopes and Instruments Karl Storz SE & CO.KG Cleared 2026-03-02 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-03-02	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)
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) Gyrus Acmi, Inc. Cleared 2026-03-02 Registered with US (FDA)	Gyrus Acmi, Inc.	2026-03-02	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)
AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses Alcon Research, Ltd. Cleared 2026-03-02 Registered with US (FDA)	Alcon Research, Ltd.	2026-03-02	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)
Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) Myofunctional Research Corp. Pty. , Ltd. Cleared 2026-03-02 Registered with US (FDA)	Myofunctional Research Corp. Pty. , Ltd.	2026-03-02	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)
UltraPrint-Dental Hard Splint UV GUANGZHOU HEYGEARS IMC.INC Cleared 2026-03-02 Registered with US (FDA)	GUANGZHOU HEYGEARS IMC.INC	2026-03-02	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)
Clarius Ejection Fraction AI Clarius Mobile Health Corp. Cleared 2026-03-02 Registered with US (FDA)	Clarius Mobile Health Corp.	2026-03-02	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)
Cordella Pulmonary Artery Sensor System (CorPASS) Endotronix, Inc. Cleared 2026-03-02 Registered with US (FDA)	Endotronix, Inc.	2026-03-02	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)
Microwave Ablation Device Nanjing Dewen Medical Technology Co., Ltd. Cleared 2026-03-02 Registered with US (FDA)	Nanjing Dewen Medical Technology Co., Ltd.	2026-03-02	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)
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) Nanjing Devin Medical Technology Co., Ltd. Cleared 2026-03-02 Registered with US (FDA)	Nanjing Devin Medical Technology Co., Ltd.	2026-03-02	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)
"FLNT Base" and "FLNT Temp" Liaoning Upcera Co., Ltd. Cleared 2026-03-02 Registered with US (FDA)	Liaoning Upcera Co., Ltd.	2026-03-02	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)
DURASEAL EXACT SPINE SEALANT SYSTEM Integra Lifesciences Corp. Cleared 2026-02-27 Registered with US (FDA)	Integra Lifesciences Corp.	2026-02-27	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)
DURASEAL DURAL SEALANT SYSTEM Integra Lifesciences Corp. Cleared 2026-02-27 Registered with US (FDA) UK (MHRA) AU (TGA)	Integra Lifesciences Corp.	2026-02-27	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Allday Moisturizing Rinse Elevate Oral Care Cleared 2026-02-27 Registered with US (FDA)	Elevate Oral Care	2026-02-27	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)
AViTA Pulse Oximeter (SP61) Avita Corporation Cleared 2026-02-27 Registered with US (FDA)	Avita Corporation	2026-02-27	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)
Ligence Heart Ligence Uab Cleared 2026-02-27 Registered with US (FDA)	Ligence Uab	2026-02-27	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)
Evala Nerve Stimulator (EPNR002) Epineuron Technologies, Inc. Cleared 2026-02-27 Registered with US (FDA)	Epineuron Technologies, Inc.	2026-02-27	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)
HKT Anatomical Locking Trauma System Hankil Tech Medical Co., Ltd. Cleared 2026-02-27 Registered with US (FDA)	Hankil Tech Medical Co., Ltd.	2026-02-27	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)
Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) Beijing HuaCheng Taike Technology Co., Ltd. Cleared 2026-02-27 Registered with US (FDA)	Beijing HuaCheng Taike Technology Co., Ltd.	2026-02-27	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)
Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) Beijing HuaCheng Taike Technology Co., Ltd. Cleared 2026-02-27 Registered with US (FDA)	Beijing HuaCheng Taike Technology Co., Ltd.	2026-02-27	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)
LigaMend Riverpoint Medical Cleared 2026-02-27 Registered with US (FDA)	Riverpoint Medical	2026-02-27	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)
VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM Medtronic Vascular Cleared 2026-02-27 Registered with US (FDA)	Medtronic Vascular	2026-02-27	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)
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) Atraverse Medical Cleared 2026-02-27 Registered with US (FDA)	Atraverse Medical	2026-02-27	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)
Evolysse® FORM SYMATESE SAS Cleared 2026-02-27 Registered with US (FDA)	SYMATESE SAS	2026-02-27	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)
C-Lant Port Vigor Medical Technologies , Ltd. Cleared 2026-02-27 Registered with US (FDA)	Vigor Medical Technologies , Ltd.	2026-02-27	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)
Atellica CH Diazo Total Bilirubin (D_TBil) Siemens Healthcare Diagnostics Cleared 2026-02-27 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Siemens Healthcare Diagnostics	2026-02-27	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
One-Stop Mediclus Co., Ltd. Cleared 2026-02-27 Registered with US (FDA)	Mediclus Co., Ltd.	2026-02-27	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)
Photodynamic Diagnostic D-Light C (PDD) System Karl Storz Endoscopy-America, Inc. Cleared 2026-02-26 Registered with US (FDA)	Karl Storz Endoscopy-America, Inc.	2026-02-26	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)
GMK 3D Metal Tibial Tray Extension Medacta International S.A. Cleared 2026-02-26 Registered with US (FDA)	Medacta International S.A.	2026-02-26	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)
ETHIZIA™ Hemostatic Patch ETHICON LLC Cleared 2026-02-26 Registered with US (FDA)	ETHICON LLC	2026-02-26	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)
NEVISENSE Scibase AB Cleared 2026-02-26 Registered with US (FDA) AU (TGA)	Scibase AB	2026-02-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm Speciality Fibres and Materials, Ltd. Cleared 2026-02-26 Registered with US (FDA)	Speciality Fibres and Materials, Ltd.	2026-02-26	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)
Enbio PRO Enbio Group AG Cleared 2026-02-26 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Enbio Group AG	2026-02-26	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
CAPRI ORO Co., Ltd. Cleared 2026-02-26 Registered with US (FDA)	ORO Co., Ltd.	2026-02-26	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)
ENOS Software Guided External Fixation System Disior, Ltd. Cleared 2026-02-26 Registered with US (FDA)	Disior, Ltd.	2026-02-26	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)
InnovexView (GC146-17, GC150-20, GC155-23) Shanghai AnQing Medical Instrument Co., Ltd. Cleared 2026-02-26 Registered with US (FDA)	Shanghai AnQing Medical Instrument Co., Ltd.	2026-02-26	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)
ANNE Maternal Sibel Health Inc. Cleared 2026-02-26 Registered with US (FDA)	Sibel Health Inc.	2026-02-26	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)
SWINGO-3D Lumbar Cage System Implanet, S.A. Cleared 2026-02-26 Registered with US (FDA)	Implanet, S.A.	2026-02-26	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)
RIB LINK™ Fixation System Globus Medical, Inc. Cleared 2026-02-26 Registered with US (FDA)	Globus Medical, Inc.	2026-02-26	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 for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device Aidoc Medical , Ltd. Cleared 2026-02-26 Registered with US (FDA)	Aidoc Medical , Ltd.	2026-02-26	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)
Copioumed AAMI 3 Surgical Gown Copioumed International Inc. Cleared 2026-02-26 Registered with US (FDA)	Copioumed International Inc.	2026-02-26	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™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid Depuy Mitek, Inc Cleared 2026-02-26 Registered with US (FDA)	Depuy Mitek, Inc	2026-02-26	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)