24 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUMAN ALBUMIN CSF KIT
FDA 510(k)
FDA Class 2
·Immunology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...
apollo
FDA UDI
MEDLINE INDUSTRIES, INC.·00818614021638·apollo 4.5mm drill
LEONE SPA
FDA UDI
LEONE SPA·08033707002833·COIL SPRINGS MEMORIA 045/010 OPEN
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981030018·PRECONTOURED ROD, 5.5 x 45mm
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319752913·Laparoscopic Monopolar Electrode 5mm w/o Suctio...
CENTRO FAMILY OF MANUAL WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
ERA IMPLANT
FDA 510(k)
FDA Class 2
·Dental
TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 7, 2018
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 20, 2013
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·June 9, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 14, 2008
CUSTOM TOTAL FEMUR REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·July 24, 2015
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·August 8, 2012
CUSTOM TOTAL FEMORAL REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·December 23, 2014
CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 1, 2014
PROXIMAL FEMUR
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·December 23, 2014
TRU CC FEMORAL SIZE 1 LEFT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 15, 2025