9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
FDA 510(k)
FDA Class 2
·Anesthesiology
KLS Martin Individual Patient Solutions (IPS) Planning System
FDA 510(k)
FDA Class 2
·Neurology
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
FDA 510(k)
FDA Class 2
·Cardiovascular
CADD-LEGACY® PCA AMBULATORY INFUSION PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.,·Product code MEA·March 29, 2016
ASCENT SYSTEM-BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 28, 2016
IMPAX DB SERVER 5.2
FDA Adverse Event
Death
·AGFA HEALTHCARE CORPORATION·Product code LLZ·February 28, 2013
SELECT SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·February 9, 2011
DIDECO ELCTRA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code CAC·July 9, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024