17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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