18 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
leva Pelvic Health System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LATIS SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TOTAL CARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 6, 2014
PFC SIGMA TIB TRAY CEM SZ3
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·August 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 13, 2016
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 7, 2013
5.0MM DIA TPRD HD PER SCRW 35
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 23, 2013
5.0MM DIA TPRD HD PER SCRW 30
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 23, 2013
PINN CAN BONE SCREW 6.5MMX40MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY - REG. # 1219655·Product code NDJ·May 23, 2013
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·May 23, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 7, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019