24 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131256157·NERA PRO, BTE 13 WL 100 STG
K131982
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 23, 2024
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
FDA 510(k)
FDA Class 1
·Ophthalmic
DHS/DCS-SCR Ø12.5 L105 SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·May 29, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·October 1, 2014
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
MOD SQUARE EXP 5.5 SI DRIVER
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code HXX·March 27, 2020
BD UNKNOW NEXIVA
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·October 17, 2024
BD NEXIVA 20GA X 1.00 IN DP WITH MAXZERO
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·October 18, 2024
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015