9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BETA FFIRM TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENCLOSE ANASTOMOSIS ASSIST DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
INMODE HAIR REMOVAL (HR) DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·March 3, 2014
ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·November 16, 2007
DUROM ACETABULAR COMPONENT 58/52 R
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·October 26, 2012
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
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015