17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intense Pulsed Light Treatment System (LK-PT)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)
Evolve Masters
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002343·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051990·
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78824244000201·EXRC MBT 022/LR4 -12T 2A
Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RELION INSULIN SYRINGE 3/10ML 29G X 8MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 22, 2022
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 27, 2014
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 27, 2014
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
ENDURANT II
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·June 27, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 11, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 23, 2013
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·June 14, 2013
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017