473 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BACT/ALERT PF PLUS CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
MaxFuse VBR, 10 (D) x 12 (W) x 56 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055660·10 (D) x 12 (W) x 56 (H)
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
FDA 510(k)
FDA Class 2
·Anesthesiology
EMERALD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064801·Corpectomy, 12Dx14Wx46H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034804·Corpectomy, 12Dx14Wx46H 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
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
CUSHION GRIP
FDA Adverse Event
Other
·Product code KOP·September 22, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·June 7, 2011
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 21, 2022