23 results
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20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
FDA 510(k)
FDA Class 2
·Ophthalmic
UNIMAX
FDA UDI
PARAMOUNT SURGICALS, INC.·00852647007122·HORIZONTAL PLATE STANDARD 42.5 MM
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122230·KWire .045x9" (1.1x225mm)
Bioseal Inc.
FDA UDI
BIOSEAL·00630094011240·Bias Stockinette
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365113772·
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BIOMEDICS UV MULTIFOCAL
FDA 510(k)
FDA Class 2
·Ophthalmic
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011
STONYBROOK HSP NY NY 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 14, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
CENTURY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 28, 2011
C21785 IT TREVISO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code GEI·December 14, 2012
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022
CP5 FLOW MODULE
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWA·July 18, 2024
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021