7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SELF-CONTAINED SURGICAL SLUSH FREEZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Stryker Resorbable Fixation System
FDA 510(k)
FDA Class 2
·Dental
QUIDEL MOLECULAR INFLUENZA A+B
FDA 510(k)
FDA Class 2
·Microbiology
MOBI-C CERVICAL DISC PROSTHESIS
FDA Adverse Event
Injury
·LDR MEDICAL·Product code MJO·June 10, 2014
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·November 23, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015