16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AETOS
FDA UDI
Smith & Nephew, Inc.·00885556920572·REVERSE INSTRUMENTS TRAY V2 BASE
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARCUS GRAFT FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MENTOR MEMORYSHAPE BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·October 9, 2024
GEENEN PANCREATIC STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·January 10, 2019
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·March 6, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·August 1, 2024
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 9, 2021
ZIMMON PANCREATIC STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 16, 2020
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