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