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

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Cook Unimpregnated Central Venous Catheter

FDA 510(k)
FDA Class 2 ·General Hospital

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·October 21, 2024

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·March 29, 2024

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·March 28, 2024

COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·December 28, 2023

ZenFlex

FDA UDI
Kerr Corporation·00195062029844·Rotary Files

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122292·Kwire .070X9" (1.8x225mm)

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027015·Sofield Retr, 1/2x2 1/4", length 7 3/4"

INDEPENDENCE SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

DMP PIT & FISSURE SEALANT

FDA 510(k)
FDA Class 2 ·Dental

SYRINGE 1.0ML 31G 6MM S/C U-100 RELION

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·April 23, 2021

ATTUNE RP TIB BASE SZ 5 CEM

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code NJL·January 5, 2018

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

GYNECARE GYNEMESH* PS

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTO·June 21, 2013

VENTILATOR, CONTINUOUS, FACILITY USE

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·July 12, 2011

MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014