21 results · 21ms · Sources: EU EUDAMED, US FDA

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CRAG LATERAL FLOW ASSAY (LFA)

FDA 510(k)
FDA Class 2 ·Microbiology

Breast Basis Set 1,5T 3T

FDA UDI
Noras MRI products GmbH·04251269200151·

Gibralt

FDA UDI
Choice Spine, LP·00840996169424·GIBRALT,DRILL,FIXED,2.4X22

SPACELABS MEDICAL PATIENT MONITORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

K-ASSAY D-DIMER CONTROLS

FDA 510(k)
FDA Class 2 ·Hematology

CM TITAMAX EX IMPLANT 3.5X9

FDA Adverse Event
Injury ·NEODENT JJGC S.A.·Product code DZE·November 9, 2017

M2A-MAGNUM PF CUP 56ODX50ID

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 14, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

ADVANTA BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·April 28, 2011

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

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

PERITX DRAINAGE BAG KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

SURGUARD3 SAFETY HYPODERMIC NEEDLE

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

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

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

EMBLEM S-ICD Model A209

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