41 results · 23ms · Sources: EU EUDAMED, US FDA

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ST AIA-PACK PROG II Calibrator Set

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MAXIM VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304205819·

MAXIM® VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00887868225888·

DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE

FDA 510(k)
FDA Class 2 ·Microbiology

T:SLIM G5 SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OYC·February 12, 2018

COBAS 8000 COBAS ISE MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 13, 2018

PAGEWRITER TC 20 CARDIOGRAPH

FDA Adverse Event
Malfunction ·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021

BREAS VIVO 60

FDA Adverse Event
Malfunction ·BREAS MEDICAL AB·Product code NOU·July 31, 2017

TRILOGY EVO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·March 13, 2025

PELVICOL (BARD) 8CM X 12CM

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 24, 2013

ANTHEM RF

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 28, 2011

CELL-DYN SAPPHIRE ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·June 16, 2014

BREAS VIVO 60

FDA Adverse Event
Malfunction ·BREAS MEDICAL AB·Product code NOU·September 15, 2015

VITROS CHEMISTRY PRODUCTS NA+ SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JGS·August 21, 2020

VITROS CHEMISTRY PRODUCTS NA+ SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JGS·August 21, 2020

VITROS CHEMISTRY PRODUCTS NA+ SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JGS·August 21, 2020

VITROS CHEMISTRY PRODUCTS NA+ SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JGS·August 21, 2020

BREAS VIVO 60

FDA Adverse Event
Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017