11 results
·
34ms
·
Sources: EU EUDAMED, US FDA
VIDEO PRINTER, MODEL 3200
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746050060·WIRE SS POSTED UNIV 019 X 025 32MM 10/PK
Expedium Spine System, VIPER and VIPER 2 Systems
FDA 510(k)
FDA Class 2
·Orthopedic
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CHIBA NEEDLE SETS COAXIAL 22G X20CM 5/CS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FCG·July 1, 2010
CHIBA NEEDLE SETS COAXIAL 22G X20CM 5/CS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FCG·July 7, 2010
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 7, 2010
DXTEND GLENOSPHERE STD D42MM
FDA Adverse Event
Injury
·DEPUY FRANCE·Product code KWS·December 6, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012