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

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KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

SONTEC-WECK TROUTMAN CORNEAL DISSECTOR

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896072374·SONTEC-WECK TROUTMAN CORNEAL DISSECTOR SINGLE E...

MIS ANTERIOR CERVICAL PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·May 15, 2013

CHARITE ARTIFICIAL DISC, SIZE UNK

FDA Adverse Event
Injury ·DEPUY SPINE, INC.·Product code MJO·May 31, 2011

CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
EDWARDS LIFESCIENCES·Product code LWR·August 11, 2008

NEEDLE, HYPODERMIC, SINGLE LUMEN

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020

TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018

NEEDLE, HYPODERMIC, SINGLE LUMEN

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019

TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018

SURGUARD3 SAFETY HYPODERMIC NEEDLE

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024

TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

FDA Adverse Event
Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 2022

HEARTMATE II SYSTEM CONTROLLER, US, EP

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·February 19, 2020

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021