9 results
·
30ms
·
Sources: EU EUDAMED, US FDA
KEISEI HANDLES FOR SURGICAL BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981143954·Trial Rasp, 18x15x12mm, 7 Deg Lordosis
Parietene DS Composite Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
INTRINSIC
FDA Adverse Event
MEDTRONIC MED REL, INC.·Product code LWS·October 9, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code CGA·December 10, 2012
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·June 22, 2023
Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016