10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CRYOPRO MAXI AND CRYOPRO MINI
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ARK Tramadol Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
ADVIA CENTAUR CEA AND BR ASSAY
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code DHX·June 27, 2008
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CEC·April 23, 2012
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·February 25, 2013
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORP, ASHITAKA·Product code DQX·February 1, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 5, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024