14 results · 21ms · Sources: EU EUDAMED, US FDA

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SPEC Model M23

FDA 510(k)
FDA Class 2 ·Radiology

QLAB QUANTIFICATION SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

DYNAFLEX

FDA 510(k)
FDA Class 2 ·Dental

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·December 19, 2017

SPRINT QUATTRO SECURE S

FDA Adverse Event
Malfunction ·MPRI·Product code LWS·October 10, 2014

K-Y BRAND PRODUCTS

FDA Adverse Event
Injury ·SKILLMAN CONTRACT·Product code KMJ·June 11, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 13, 2011

STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code LJS·October 1, 2018

TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code LJS·October 1, 2018

Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017