9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
FDA 510(k)
FDA Unclassified
·Unknown
Barco
FDA UDI
FIMI SRL·05415334002302·MDSC-8427 12G
BARCO
FDA UDI
Barco NV·05415334042711·MDSC-8532 SSTF BL
COAGULATION REFERENCE PLASMA, NORMAL
FDA 510(k)
FDA Class 2
·Hematology
D-DIMER WELLCOTEST (HA10)
FDA 510(k)
FDA Class 2
·Hematology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 30, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·December 4, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 3, 2014
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013