7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
FDA 510(k)
FDA Class 1
·Ophthalmic
COR DOT CMV
FDA 510(k)
FDA Class 2
·Microbiology
VENTREZYME THEOPHYLLINE IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 10, 2014
REAMER Ø11 F/FEM-NECKSCR L440 NO. 511.76
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·December 10, 2012
NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·June 23, 2015
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