12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Trinity Acetabular Hip System
FDA UDI
CORIN LTD·05055343866849·Offset Drive Train – Open (subcomponent)
Optilume Basic Urological Balloon Dilation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMPLICITGUIDE SURGICAL SUTURE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLORADO 2 SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code MNH·December 4, 2009
COLORADO II SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MNH·May 19, 2017
COLORADO SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 17, 2016
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 6, 2013
VIRTUOSO DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011
MAXIMO II DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 8, 2014
COLORADO II SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·July 26, 2011
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025