10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MODEL ICPM & ACCESSORIES
FDA 510(k)
FDA Class 1
·Physical Medicine
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
FDA 510(k)
FDA Class 2
·Radiology
RENEGADE STC 18 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ECHOTIP ULTRA ENDOBRONCHIAL ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·March 15, 2013
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
DYNESYS IMPLANT
FDA Adverse Event
Other
·ZIMMER GMBH·Product code NQP·October 26, 2012
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
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
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