22 results · 22ms · Sources: EU EUDAMED, 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