13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
PILLAR CHIN IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CIRCUITGUARD CIRCUITGUARD HME
FDA Adverse Event
Other
·ARC MEDICAL INC., ANESTHESIA & RESPIRATORY CARE·Product code BYD·July 20, 2005
ROSA SURGICAL DEVICE, MODEL ROSA 1.1
FDA 510(k)
FDA Class 2
·Neurology
WavelinQ Plus EndoAVF System
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·June 11, 2009
HEARTMATE XVE
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 7, 2013
MAXIMO II VR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011
CONSULTA CRT-P
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NVZ·August 8, 2014
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX PEDICSCR Ø6.2 L50 TAN DBLUE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021