9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BIO-TENS
FDA 510(k)
FDA Class 2
·Neurology
CORDOT R
FDA 510(k)
FDA Class 2
·Microbiology
6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM-STERILE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HSB·June 21, 2017
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code LJS·April 24, 2014
MARQUIS VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 19, 2010
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·December 15, 2012
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·March 13, 2019
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024