11 results
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22ms
·
Sources: EU EUDAMED, US FDA
RESTING PAN SPLINTS
FDA 510(k)
FDA Class 1
·Physical Medicine
KSEA CLEARVISION II, MODEL 40334120
FDA 510(k)
FDA Class 2
·Neurology
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
FDA 510(k)
FDA Class 2
·Anesthesiology
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM-TIBIAL TRAY
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 21, 2017
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT-PATELLA
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 21, 2017
ASCENT SYSTEM - FEMORAL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 21, 2017
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 4, 2012
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 13, 2014
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·July 23, 2010
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·January 20, 2016
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026