8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SYNELISA DHEA-SULFATE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
FDA 510(k)
FDA Class 2
·Microbiology
JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 16, 2025
FLEXOR RAABE GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DYB·December 21, 2010
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·January 4, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 3, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015