55 results · 23ms · Sources: EU EUDAMED, US FDA

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BTL-084

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994399984·PLATE 6190023 23MM

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690196471·EVO Stylus 2mm / 10mm

Q-Rejuvalight Pro Facewear

FDA UDI
Light Tree Ventures Europe B.V.·08719327598719·

Q-Rejuvalight Pro Facewear (Model: P19-0023)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E

FDA 510(k)
FDA Class 2 ·Neurology

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Portico Transcatheter Aortic Valve Implantation System

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 18, 2025

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Portico™ Transcatheter Aortic Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Navitor™ TAVI System with Vision Technology

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Navitor Transcatheter Aortic Valve Implantation System