14 results · 19ms · Sources: EU EUDAMED, US FDA

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COX MALAR EMINENCE IMPLANTS

FDA 510(k)
FDA Class 2 ·Ophthalmic

MICRO DIARY SPIROMETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)
FDA Class 2 ·Microbiology

GEENEN PANCREATIC STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·January 10, 2019

APTIMA HPV SCREENING ASSAY

FDA Adverse Event
Injury ·HOLOGIC, INC.·Product code OYB·October 15, 2024

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·June 27, 2014

STRYKER STANDARD VIDEO CART W/ISOLATION TRANSFORMER

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·November 10, 2010

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

UNKNOWN

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

ZIMMON PANCREATIC STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

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