7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
JAKOBI SURG. INSTRUMENTS #11 11/13/14
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WESTERGREN DISPETTE FOR ESR
FDA 510(k)
FDA Class 1
·Hematology
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 28, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 15, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 14, 2010
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