9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756718035·RADIOLOGY SPECIAL PROCEDURE PK
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PATIENT EXAMINATION GLOVES (NATURAL RUBBER)
FDA 510(k)
FDA Class 1
·General Hospital
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 19, 2014
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·December 28, 2012
G7 FREEDOM AND OFFSET LINERS, FREEDOM HEAD, SIZE 32
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·March 23, 2017
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