17 results · 28ms · Sources: EU EUDAMED, US FDA

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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