18 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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