8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SHILEY DISPOS. DECANNULATION PLUG W/SW/
FDA 510(k)
FDA Class 2
·Anesthesiology
Xpert C. difficile/Epi
FDA 510(k)
FDA Class 2
·Microbiology
GBR System
FDA 510(k)
FDA Class 2
·Dental
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 12, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·October 26, 2012
TOTALCARE PULMONARY SURFACE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·September 21, 2010
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
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