14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
THE GOLDEN QUAD TEST (EBV)
FDA 510(k)
FDA Class 1
·Microbiology
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981146382·Angled DTS Awl
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162930·SUPPLIES - IMPRESSION TRAY SAMPLE KIT 20 TRAYS
Impression Tray
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746035043·SUPPLIES - IMPRESSION TRAY SAMPLE KIT 20 TRAYS
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746034862·SUPPLIES - IMPRESSION TRAY SAMPLE KIT 20 TRAYS
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861121180·Standard Band, Tooth 44/34, Size 21/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861121220·Standard Band, Tooth 44/34, Size 21/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861121000·Standard Band, Tooth 45-44/34-35, Size 21
MICROTHIN-P1 (MOD. 0622)
FDA 510(k)
FDA Class 3
·Cardiovascular
ELECTRIC VIBRATOR
FDA 510(k)
FDA Class 1
·Physical Medicine
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
DUAL EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 4, 2012
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