14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFIRA
FDA 510(k)
FDA Class 2
·General Hospital
Sapphire NC Plus
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955916717·Percutaneous Transluminal Coronary Angioplasty ...
VAXCEL WITH PASV PORT
FDA 510(k)
FDA Class 2
·General Hospital
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 3, 2022
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 20, 2022
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011
PRINEO SKIN CLOSURE SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OMD·July 16, 2013
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
MEDROXYPROGESTERONE ACETATE
FDA Adverse Event
Malfunction
·LABORATORIES FARMALAN S.A.·Product code FMF·July 15, 2024
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·October 13, 2023
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
FDA Enforcement
Class II
·Ongoing·SenTec AG·September 27, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025