10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
WILDCAT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
KSEA CLEARVISION LENS IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
R3 XLPE INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·May 1, 2014
UNKNOWN DEPUY ACETABULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 15, 2013
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2011
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025