23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
FDA 510(k)
FDA Class 2
·Ophthalmic
ArgenZ HT+ 98x12 A3
FDA UDI
ARGEN CORPORATION, THE·D818121993·Dental porcelain/ceramic restoration kit
SHANCHUAN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
VIPER SYSTEM, EXPEDIUM SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BLACK HANDLED METZENBAUM SCISSORS
FDA Adverse Event
Other
·PILLING·Product code LRW·August 4, 1993
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·August 17, 2020
INFUSION PUMP
FDA Adverse Event
Malfunction
·MCGAW-HORIZON·Product code FRN·March 15, 1993
INFUSION PUMP
FDA Adverse Event
MCGAW-HARIZON·Product code FRN·March 15, 1993
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 21, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 9, 2011
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 13, 2008
ADVIA CENTAUR CP CA15-3 ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEATHCARE DIAGNOSTICS, INC.·Product code MOI·November 18, 2015
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021
MICRO PROCESSOR VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code BTL·August 31, 1993
TRISTAR ENDOPATH TROCAR
FDA Adverse Event
ETHICON ENDOSURGERY DIVISION OF JOHNSON AND JOHNSON·Product code KDC·August 31, 1993
CENTURY TUB (WHIRLPOOL) LIFT
FDA Adverse Event
Malfunction
·CENTURY MANUFACTURING CO.·Product code ILJ·February 8, 1993
INVACARE INNOVATION IN HEALTH CARE
FDA Adverse Event
Death
·INVACARE INNOVATION IN HEALTH CARE·August 31, 1993
MESHGRAFT II WITH RATCHET
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·July 17, 2013
SYNVISC
FDA Adverse Event
Injury
·BIOMATRIX, INC.·Product code MOZ·December 23, 1998
UNKNOWN SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·April 29, 2022