11 results
·
35ms
·
Sources: EU EUDAMED, US FDA
RUBENOSTIKA IGG MICROELISA SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
RANDOX PHENYTOIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SNAP (R) WOUND CARE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIBERTE MONORAIL CORONARY STENT DEL SYS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·October 27, 2006
UNI LFIT MEDIAL FEMORAL COMP.
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code HRY·April 15, 2013
LEVEL 1 HOTLINE LOW FLOW SYSTEMS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LGZ·January 23, 2024
LEVEL 1 HOTLINE LOW FLOW SYSTEMS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LGZ·January 23, 2024
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 24, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2014
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025