16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES EXTERNAL MIDFACE DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025
TruLock
FDA UDI
Rmo, Inc.·00885797644947·TRULOCK Primer Activated Adhesive Mini Kit (1ea...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735220·Ingrown Nail Cutter, S/S hook edge
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935103448·
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
FDA 510(k)
FDA Class 2
·Cardiovascular
EBI XFIX DFS RAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONTOUR CURVED CUTTER STAPLER CS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 8, 2013
CD HORIZON
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 29, 2010
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 8, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 5, 2011
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Injury
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·May 7, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 6, 2020
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018