8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
FDA 510(k)
FDA Class 2
·Orthopedic
FINAL VARNISH LC
FDA 510(k)
FDA Class 2
·Dental
LONG NAIL KIT R1.5, LEFT 10X260MM X 125
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010
DEPUY ASR FEM IMPLANT SZ 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·January 28, 2013
MATRIX DETACHABLE COILS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·December 16, 2010
MINILINK TRANSMITTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·July 12, 2014
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013