9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
URINE COLLECTION KIT/DEVICE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Clue Birth Control
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CABLECAP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MULTI SPECT 2 [510(K) K913630]
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code IYX·April 13, 2001
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 14, 2014
LIVIAN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 14, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 11, 2010
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020