13 results · 21ms · Sources: EU EUDAMED, US FDA

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NuVasive NuvaLine

FDA 510(k)
FDA Class 2 ·Radiology

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741924350·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674192435060·

BEYONDIMAGE WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

VERSEO AIR PRESSURE MASSAGER

FDA 510(k)
FDA Class 2 ·Physical Medicine

UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

FDA Adverse Event
Malfunction ·STAAR SURGICAL CO.·Product code HQL·November 4, 2004

COPIOS PERICARDIUM MEMBRANE

FDA Adverse Event
Injury ·Product code NPL·June 10, 2020

RHYTHMIA HDX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

PROTECTIV PLUS-W SAFETY I.V CATHETER RADIOPAQUE 20X11/4

FDA Adverse Event
Injury ·MFG FOR SMITHS MEDICAL BY: MEDEX·Product code FOZ·October 7, 2008

ENDURON 10D 54OD X 28ID

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·June 27, 2013

LEAD MODEL 304

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·July 27, 2011

Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

FDA Enforcement
Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018