20 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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Triathlon® Hinge Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
ZESPIN SI Joint Fusion System
FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm
ENDER NAIL
FDA UDI
Smith & Nephew, Inc.·03596010104403·3.5MM DIAMETER NAIL 3.5MMX28CM
...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021371·FPS 3.5mm x 28mm Locking Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075787·FPS 3.5 x 28mm Locking Screw Sterile Qty 2
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
FDA 510(k)
FDA Class 2
·Orthopedic
SCENIUM
FDA 510(k)
FDA Class 2
·Radiology
GMK SPHERE CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
CELL-DYN RUBY ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 25, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 12, 2013
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026