18 results · 34ms · Sources: EU EUDAMED, US FDA

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IFS Fixation Scaffold System

FDA 510(k)
FDA Class 2 ·Orthopedic

MILLENIUM ANTI-SNORING DEVICE

FDA 510(k)
FDA Class 2 ·Dental

GIO DIGITAL PRESSURE GUAGES

FDA 510(k)
FDA Class 2 ·Anesthesiology

EXPRESS SD RENAL/BILIARY

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

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025

BASIX COMPAK INFLATION SYRINGE KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 7, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

AXSYM RUBELLA IGG ANTIBODY

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code LFX·September 10, 2008

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·February 15, 2016

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·February 15, 2016

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·February 15, 2016

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 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