7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
JAKOBI SURG. INSTRUMENTS #12 40/41
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
FDA 510(k)
FDA Class 2
·General Hospital
CPR HEARTSAVER AND BREATHOLATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SROM STM STD 36+12L 13X18
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code LPH·May 28, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·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