154 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776163419·Farrior Spec Oval Oblique . Ebonized
EVONOS GMBH & Co. Kg
FDA UDI
Gyrus ACMI, LLC·00821925014428·EAR SURGERY SPECULUM ROUND 8.0MM
Biogel
FDA UDI
Bosma Enterprises·10818634023541·Biogel Sensor Surgical 8.0 - 50 Pair/Box
LINK Instruments - Chisel, bone curette, raspatory, rongeur
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575033331·Orthopaedic prosthesis instrument, reusable - G...
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776313258·Farrior Speculum Oval Oblique
MICROLIFE DIGITAL UNDERARM THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 30, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·June 10, 2011
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·June 15, 2016
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 15, 2024
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
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 22, 2020
CAPIOX FX05
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 21, 2020
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 1, 2022