24 results · 24ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

FDA 510(k)
FDA Class 2 ·Hematology

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 17, 2021

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 18, 2021

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·October 17, 2021

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·July 16, 2021

FLEX-NAILS

FDA 510(k)
FDA Class 2 ·Orthopedic

AGILTRAC .018 PERIPHERAL DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM

FDA Adverse Event
Injury ·BERLIN HEART GMBH·Product code DSQ·June 27, 2022

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 26, 2013

SECURE 3 MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·March 10, 2011

EMBRACE PUMP

FDA Adverse Event
Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·March 26, 2008

TENOR SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

TENOR SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010

O-ARM IMAGING SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·January 13, 2023

MEDTRONIC NAVIGATION

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·January 13, 2023

MEDTRONIC NAVIGATION

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·January 13, 2023

SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code LMG·May 15, 2023

UNKNOWN

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·October 19, 2022

BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM

FDA Adverse Event
Injury ·BERLIN HEART GMBH·Product code DSQ·June 27, 2022