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

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SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)

Cadwell

FDA UDI
Technomed Engineering B.V.·08720791377427·Disposable Hypodermic Needle Electrode, green hub

Technomed Europe

FDA UDI
Technomed Engineering B.V.·08718375865538·Disposable Hypodermic Needle Electrode, green hub

MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479

FDA 510(k)
FDA Class 2 ·Microbiology

VITROS 5, 1 FS CHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·October 8, 2008

TRIATHLON PS X3 TIBIAL INSERT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 5, 2011

RESOLUTION CLIP CLIPPING DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 2, 2013

COBAS 8000 C (701) MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 16, 2017

COBAS 8000 C (701) MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 13, 2017

TRICLIP DELIVERY SYSTEM (TCDS)

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code NPS·June 26, 2024

1823260-2017-00824

FDA Adverse Event
Malfunction ·April 19, 2017

3.0 RIO ROBOTIC ARM - MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 8, 2019

MEDTRONIC CRT-D

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NIK·December 8, 2021

MEDTRONIC LEAD

FDA Adverse Event
Death ·MEDTRONIC, INC.·Product code DXY·December 8, 2021

MEDTRONIC ICD

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DXY·December 8, 2021

MEDTRONIC LEAD

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DXY·December 8, 2021

TRICLIP DELIVERY SYSTEM (TCDS)

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code NPS·June 26, 2024