44 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ACTIVE ELECTRODE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·10885862161253·
Zavation
FDA UDI
Zavation LLC·00842166122185·4-Level, 80mm Cervical Plate
APEX Spine System
FDA UDI
SPINECRAFT, LLC·00193082155796·APEX Ti Rod Dia. 6 x 480mm, Straight
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004800·
Cadwell
FDA UDI
CADWELL INDUSTRIES, INC.·00840067103852·RIPmate Kit
CURE ACP
FDA UDI
SpineArt SA·07640270065755·ANTERIOR CERVICAL PLATE, 4 LEVELS L80
Cadwell
FDA UDI
CADWELL INDUSTRIES, INC.·00840067103753·RIPmate Abdominal Kit
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520004800·Curved Ti Rod, 480mm
Cadwell
FDA UDI
CADWELL INDUSTRIES, INC.·00840067103722·RIPmate Thoracic Kit
Ultra Vac
FDA UDI
I.C. MEDICAL, INC.·00817688020288·
ASNIS III CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CURE ACP
FDA UDI
SpineArt SA·07640270066264·ANTERIOR CERVICAL PLATE, 4 LEVELS L80
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004800·
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640375231741·CERVICAL 4 LEVEL TEMPLATE L80
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640375234162·ANTERIOR CERVICAL PLATE, 4 LEVELS L80
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·May 27, 2024
DREAMSTATION 2 ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 3, 2025
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 8, 2024