11 results
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36ms
·
Sources: EU EUDAMED, US FDA
RIA KIT, PROSTATIC ACID
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916490262·MIS Fenestrated Screw M, Ø10.5 x 80mm, Ø6.0mm Rod
NADIA SI Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI MATRIXNEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
HALO90 ABLATION CATHETER
FDA Adverse Event
Other
·BARRX MEDICAL, INCORPORATED·Product code GEI·August 3, 2010
UNSPECIFIED BD ALARIS INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 28, 2021
BD ALARIS¿ SECONDARY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 24, 2023
UNSPECIFIED BD ALARIS¿ INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 29, 2022
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018