15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Erchonia Zerona Z-Bed
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220519070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220519000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220519150·
LEONE SPA
FDA UDI
LEONE SPA·08033707022466·CALIBRA BANDS 2ND MOLAR n.SUR 19
CarboClear® II Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
OrthoNext Platform System
FDA 510(k)
FDA Class 2
·Radiology
BD MICROLANCE¿3 NEEDLE 18G
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 29, 2023
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH LTD./HUNTINGTON·Product code MFK·October 29, 2008
COMPOUNDERS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code NEP·August 23, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·June 9, 2022
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021