9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ORTHO WRAP
FDA 510(k)
FDA Class 1
·General Hospital
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435062452·MCD Screw 3.0 x 22 mm M2
non lo...
AXIOM BIOLASER LLLT SERIES-1
FDA 510(k)
FDA Class 2
·Physical Medicine
EXTENSION LINE
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 23, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 13, 2012
RIATA ST OPTIM PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018