474 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776296209·Rowland Osteotome, V cutting edge, blunt
MaxFuse VBR, 10 (D) x 12 (W) x 46 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055462·10 (D) x 12 (W) x 46 (H)
EUCLID (TM) TIER 1-GW ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CEROS TCP GRANULES
FDA 510(k)
FDA Class 2
·Dental
UniTip Catheter
FDA UDI
Unisensor AG·07640172971369·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973233·
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034330·Corpectomy, 12Dx14Wx26H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034149·Corpectomy, 12Dx14Wx26H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929059500·Convexx Corpectomy, 12Dx14Wx26H, 6°
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2025
GMK-SPHERE PATELLA RESURFACING SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2019
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025
GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2016
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 10, 2021
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 2, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 30, 2026
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 26, 2019