23 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VAGINAL APPLICATOR SHIELDED
FDA 510(k)
FDA Class 2
·Radiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65890015440·20/20 Light Curing Hybrid Composite (3G A2)
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·09010782022658·CC/ Opaque Dentine OD-44 (cuba)
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0015441·CC/ Opaque Dentine OD-44 (cuba) 15g
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001544·artVeneer life upper anteriors, IS, BL1
Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres
FDA UDI
SCANLAN INTERNATIONAL INC·00846159000597·Scanlan® VASCU-STATT® II approximator single-us...
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
FDA 510(k)
FDA Class 1
·Ophthalmic
PRESS SENTINEL FLEX IM REAMER 10.5MM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HWE·March 8, 2017
PRESS SENTINEL FLEX IM REAMER 9.5 MM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HWE·March 8, 2017
DYNESYS PEDICLE+SET SCREW 6.0X40
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code NQP·March 11, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 26, 2011
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD/ HUNTINGTON·Product code MFK·February 21, 2008
EX-PRESS GLAUCOMA FILTRATION DEVICE
FDA Adverse Event
Injury
·OPTONOL LTD.·Product code KYF·February 8, 2023
EX-PRESS GLAUCOMA FILTRATION DEVICE
FDA Adverse Event
Injury
·OPTONOL LTD.·Product code KYF·February 8, 2023
EX-PRESS GLAUCOMA FILTRATION DEVICE
FDA Adverse Event
Injury
·OPTONOL LTD.·Product code KYF·February 8, 2023
EX-PRESS GLAUCOMA FILTRATION DEVICE
FDA Adverse Event
Injury
·OPTONOL LTD.·Product code KYF·February 8, 2023
MENTOR SILTEX ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·July 1, 2018
8.0MM FLEXIBLE SHAFT 440MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTO·February 27, 2018
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
FDA Enforcement
Class II
·Terminated·Motion Concepts·September 24, 2014