8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Mistral-Air Warming Unit
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293111·
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
FDA 510(k)
FDA Class 1
·Microbiology
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
FDA 510(k)
FDA Class 2
·Cardiovascular
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·October 14, 2014
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 14, 2013
COULTER ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
FDA Enforcement
Class II
·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 2017