14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEO-VAGINA SURGERY SET AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071754·STRIPE GAME ORION, SIZE XXL, RUBINO, GRADUATED ...
MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EXEL SECURETOUCH PTP SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 16, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 22, 2013
PROXIMATE** RELOADABLE VASCULAR LINEAR STAPLER - 30 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 28, 2011
UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code MMI·July 8, 2008
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012