22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Drive Rail System
FDA 510(k)
FDA Class 2
·Orthopedic
Zavation
FDA UDI
Zavation LLC·00842166133013·Ti3Z CIF 14mmx16mmx9mm -8 deg
HUMERIS 135
FDA UDI
FX SOLUTIONS·03701037310427·HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD PE/TA6...
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037311578·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD ...
D-LUX+
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BAB FLEXIBLE FABRIC BANDAGES
FDA Adverse Event
Injury
·JOHNSON & JOHNSON COMPANY INC·Product code KGX·April 18, 2023
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·November 17, 2015
SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, INC.·Product code DSQ·October 30, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LTJ·August 23, 2011
M2A 38MMX52MM CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 11, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·August 30, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·August 30, 2022
NEEDLE 21GA 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 6, 2024
NEEDLE 21GA 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 6, 2024
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019