546 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RETRACTION PASTE
FDA 510(k)
FDA Unclassified
·Unknown
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925013988·HOUSE TYPE STRAIGHT CHISEL
Biogel
FDA UDI
Bosma Enterprises·10818634023466·Biogel M Surgical 8.0 - 50 Pair/Box
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G223130580270·Drum Scraper OL 147mm (5 7/8")
SURETEMP PLUS
FDA 510(k)
FDA Class 2
·General Hospital
EXSALT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
CAPIOX FX OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 30, 2019
FOGARTY ADHERENT CLOT CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DXE·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·June 14, 2011
XP- CR Tibial Tray- Interlok 59mm Item # 195268
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
CAPIOX®FX
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 19, 2026
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 9, 2022
CAPIOX®FX
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 30, 2026
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 6, 2025
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 25, 2021
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 15, 2024
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 18, 2022
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021