20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Integrity Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDER NAIL
FDA UDI
Smith & Nephew, Inc.·03596010104502·3.5MM DIAMETER NAIL 3.5MMX38CM
...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021425·FPS 3.5mm x 38mm Locking Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075886·FPS 3.5 x 38mm Locking Screw Sterile Qty 2
EPIEN ROOT CANAL CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
FDA 510(k)
FDA Class 2
·General Hospital
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
JUVEDERM ULTRA XC TSK US
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·October 29, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
JAGWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·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
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