11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ULTRACLONE 05-100 GUINEA PIG RBC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994843029·MODULE 1854206 SOLERA S4HI HK TRIAL MOD
Legacy™3 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307102090·Ø4.2 x 6 Platform 3.5mmD
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209126828·
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·January 29, 2026
Power wheelchair (ZS-EW8026)
FDA 510(k)
FDA Class 2
·Physical Medicine
EUGONIC AGAR
FDA 510(k)
FDA Class 1
·Microbiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 6, 2014
ANGIO-SEAL DEVICE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·November 29, 2012
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·September 3, 2010
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