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.

3,689 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
VALIANT THORACIC STENT GRAFT 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)
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)
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)
Aster Osteonic Co., Ltd. Cleared 2026-02-26 Registered with US (FDA)	Osteonic 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)
Owl Night Guard Owl Dental Lab, Inc. Cleared 2026-02-26 Registered with US (FDA)	Owl Dental Lab, 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)
KARL STORZ ICG Imaging System with RUBINA® Lens Karl Storz SE & CO.KG Cleared 2026-02-26 Registered with US (FDA)	Karl Storz SE & CO.KG	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)
Konig Bell Circumcision Clamp Medline Industries, Inc. Cleared 2026-02-25 Registered with US (FDA)	Medline Industries, Inc.	2026-02-25	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)
Mako Total Knee Application Mako Surgical Corp. Cleared 2026-02-25 Registered with US (FDA)	Mako Surgical Corp.	2026-02-25	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)
Remi Impression Material Grindguard, Inc. Cleared 2026-02-25 Registered with US (FDA)	Grindguard, Inc.	2026-02-25	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)
Ventana™ A Anterior Lumbar Interbody System Spinal Elements, Inc. Cleared 2026-02-25 Registered with US (FDA)	Spinal Elements, Inc.	2026-02-25	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 Zhejiang Yikang Medical Technology Co Ltd Cleared 2026-02-25 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Zhejiang Yikang Medical Technology Co Ltd	2026-02-25	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
FIREFLY Pedicle Screw Navigation Guide Mighty Oak Medical, Inc. Cleared 2026-02-25 Registered with US (FDA)	Mighty Oak Medical, Inc.	2026-02-25	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)
BD Surgiphor™ Antimicrobial Irrigation System (910110) BECTON DICKINSON AND COMPANY (BD) Cleared 2026-02-25 Registered with US (FDA)	BECTON DICKINSON AND COMPANY (BD)	2026-02-25	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)
Diode Laser Therapy Systems (WLA-02) Wingderm Electro-Optics , Ltd. Cleared 2026-02-24 Registered with US (FDA)	Wingderm Electro-Optics , Ltd.	2026-02-24	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)
OSTEOMNI SPINAL FIXATION SYSTEM OSTEOMNI, Inc. Cleared 2026-02-24 Registered with US (FDA)	OSTEOMNI, Inc.	2026-02-24	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)
OSSIOfiber Suture Anchor OSSIO , Ltd. Cleared 2026-02-24 Registered with US (FDA)	OSSIO , Ltd.	2026-02-24	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)
Swift Ray 1 SWIFT MEDICAL INC. Cleared 2026-02-24 Registered with US (FDA)	SWIFT MEDICAL INC.	2026-02-24	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)
IntraSight Plus Philips Image Guided Therapy Corporation Cleared 2026-02-24 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Philips Image Guided Therapy Corporation	2026-02-24	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Electric wheelchair (W1,W3) Shenzhen Zhimahuaerkai Technology Co, Ltd Cleared 2026-02-24 Registered with US (FDA)	Shenzhen Zhimahuaerkai Technology Co, Ltd	2026-02-24	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)
XSense Cryoablation System with Cryoprobes ICECURE MEDICAL LTD. Cleared 2026-02-24 Registered with US (FDA)	ICECURE MEDICAL LTD.	2026-02-24	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)
AI Platform 2.2 (AIP002) Exo Imaging, Inc. Cleared 2026-02-24 Registered with US (FDA)	Exo Imaging, Inc.	2026-02-24	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)
SP Electrocautery Device (SP20) Single Pass, Inc. Cleared 2026-02-24 Registered with US (FDA)	Single Pass, Inc.	2026-02-24	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)
HemoSphere Nano Monitor (HSNANO1) Edwards Lifesciences, LLC Cleared 2026-02-24 Registered with US (FDA)	Edwards Lifesciences, LLC	2026-02-24	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)
NanoPress 760A-BT (760A-BT) Mego Afek Cleared 2026-02-24 Registered with US (FDA)	Mego Afek	2026-02-24	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)
VITA VMLC Primer VITA Zahnfabrik H Rauter GmbH & Co KG Cleared 2026-02-23 Registered with US (FDA)	VITA Zahnfabrik H Rauter GmbH & Co KG	2026-02-23	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.Ace; MAGNETOM Flow.Plus Siemens Shenzhen Magnetic Resonance , Ltd. Cleared 2026-02-23 Registered with US (FDA)	Siemens Shenzhen Magnetic Resonance , Ltd.	2026-02-23	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)
Duet™ Spinal Fixation System Box Spine, LLC Cleared 2026-02-23 Registered with US (FDA)	Box Spine, LLC	2026-02-23	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 Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) Smart Reactors Cleared 2026-02-23 Registered with US (FDA)	Smart Reactors	2026-02-23	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)
LUX Expandable Lumbar Interbody System Xenix Medical Cleared 2026-02-23 Registered with US (FDA)	Xenix Medical	2026-02-23	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)
Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe Cmt Health Pte., Ltd. Cleared 2026-02-23 Registered with US (FDA)	Cmt Health Pte., Ltd.	2026-02-23	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)
Rubber Utility Catheter C.R. Bard, Inc. Cleared 2026-02-23 Registered with US (FDA) Canada (Health Canada)	C.R. Bard, Inc.	2026-02-23	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) Applied Medical Resources Cleared 2026-02-23 Registered with US (FDA)	Applied Medical Resources	2026-02-23	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)
ARCHITECT TOTAL PSA Abbott Laboratories Cleared 2026-02-23 Registered with US (FDA)	Abbott Laboratories	2026-02-23	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)
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) POSKOM Co., Ltd. Cleared 2026-02-23 Registered with US (FDA)	POSKOM Co., Ltd.	2026-02-23	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)