8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VASCU-STATT APPROXIMATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SAM JUNCTIONAL TOURNIQUET
FDA 510(k)
FDA Class 2
·Cardiovascular
BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGASURE HS XTD DISP ELEC/CORD
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 1, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·November 16, 2007
PROFILER BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code DQY·October 10, 2012
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 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