7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MICRO-AIRE 4220-000 OSCILLATING SAW
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENZYMUN TEST(R) TSH-S
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BARD EXTRACORPOREAL CIRCULATION CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
DUR MAR 10D LINER 28IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 18, 2010
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 1, 2014
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