17 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)
FDA 510(k)
FDA Class 2
·Hematology
NA
FDA UDI
Smith & Nephew, Inc.·00885554006520·SOD CURVED RASP
HTF-HEPES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MASUNAGA since 1905
FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644463558·
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·January 31, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FNL·November 10, 2010
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·July 10, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 10, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·June 23, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·June 2, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·October 1, 2014