12 results
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20ms
·
Sources: EU EUDAMED, US FDA
Zenith Micro Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
TMS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036089382·
NA
FDA UDI
Exactech, Inc.·10885862524188·TRIAL, TIBIAL INSERT, SPACER, SIZE 3, SIZE 3.5,...
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Stretta Catheter
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·March 15, 2018
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 14, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 17, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 23, 2013
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 7, 2018
POLYMETHYLMETHACRYLATE BONE CEMENT
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code NDN·May 12, 2017
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 28, 2022