9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRACHESTOMY & NASAL SUCTIONING KIT #-
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INFINITY CENTRALSTATION WITH INFINITY M300
FDA 510(k)
FDA Class 2
·Cardiovascular
Pain Therapy Device(Model: P.T.S-X)
FDA 510(k)
FDA Class 2
·Physical Medicine
ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 23, 2014
PENUMBRA SEPARATOR 032
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·March 15, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 13, 2012
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018