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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

NuVasiveNVM5 System

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

21.3INCH MONOCHROME LCD MONITOR

FDA 510(k)
FDA Class 2 ·Radiology

CORELEADER ALGIPLASTER MODEL AP 050501

FDA 510(k)
FDA Unclassified ·Unknown

WALLSTENT RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

AMISTEM C CEMENTED LAT STEM SIZE 1

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 31, 2019

WALLSTENT ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 22, 2025

WALLSTENT ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 1, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 8, 2014

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MPRI·Product code OJX·June 8, 2013

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 17, 2011

WALLSTENT? RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022