12 results
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20ms
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Sources: EU EUDAMED, US FDA
ELPER(TM) BARRIER INTEGRITY MONITORING
FDA 510(k)EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065
FDA 510(k)
FDA Class 2
·Cardiovascular
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 9, 2023
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 28, 2013
PUMP MMT-722NAL PRDGM INSULIN CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·December 8, 2010
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 14, 2014
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 3, 2024
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
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024