11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
FDA 510(k)
FDA Class 1
·Microbiology
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S
FDA 510(k)
FDA Class 2
·Dental
QUPID PLUS E.R.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 28, 2015
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·January 28, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 10, 2010
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 17, 2013
COULTER LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 8, 2014
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 12, 2012
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 26, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021