19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Geo Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515026926·Deaver Retr, hollow grip hndl, 3"x12"
VENFLON 2 BL 22GA IV CANNULA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·July 14, 2021
BD VENFLON¿ IV CANNULA
FDA Adverse Event
Malfunction
·Product code FOZ·September 28, 2021
SYRINGE WITH HANDI-FIL
FDA 510(k)
FDA Class 2
·Cardiovascular
D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
FDA 510(k)
FDA Unclassified
·Unknown
VENFLON 2 BL 22GA IV CANNULA
FDA Adverse Event
Malfunction
·Product code FOZ·July 16, 2021
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 17, 2019
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 17, 2019
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 17, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 17, 2019
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 21, 2013
VENTILATOR, CONTINOUS, FACILITY USE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·July 7, 2011
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
cobas 6000 analyzer series Operators Manual Roche cobas; 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