13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIVORTE BVF LITE
FDA 510(k)
FDA Class 2
·Orthopedic
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 9, 2023
CORTEX SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 28, 2013
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·December 8, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 14, 2014
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
BD GEM V/NV 20D 0.2 FLTR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·July 28, 2022
GEM V/NV NTG 20DP 20PK
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 10, 2020
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·January 20, 2023
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014