14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PressON Spinal Fixation 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.·03596010104410·3.5MM DIAMETER NAIL 3.5MMX29CM
...
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044201130·Sterile 30 mL Freestanding Centrifuge Tubes wit...
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VASSALLO GT Hybrid
FDA 510(k)
FDA Class 2
·Cardiovascular
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 4, 2025
ARTIS Q ZEEGO
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 25, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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