22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Wrap Accessory Electrodes
FDA 510(k)
FDA Class 2
·Neurology
TWINFIX
FDA UDI
Smith & Nephew, Inc.·03596010498526·DISP THRD DLTOR FOR TWINFX AB 6.5
DG Gel 8 ABO/Rh+Kell
FDA UDI
DIAGNOSTIC GRIFOLS SA·08437014205015·The DG Gel 8 ABO/Rh + Kell card is for the dete...
DG Gel 8 ABO/Rh+Kell
FDA UDI
DIAGNOSTIC GRIFOLS SA·08437014205923·The DG Gel 8 ABO/Rh + Kell card is for the dete...
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551068365·BRW/CRW KIT: 2103-26, 2103-33, 2103-40, 2103-45...
TEMP SCAN
FDA 510(k)
FDA Class 2
·General Hospital
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
FDA 510(k)
FDA Class 2
·Anesthesiology
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
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR DEVICES·Product code MGB·October 13, 2008
C-FLEX ASPHERIC
FDA Adverse Event
Injury
·RAYNER INTRAOCULAR LENSES LTD·Product code MSS·August 8, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
GALAXY G3 4MM X 7CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
GALAXY G3 XSFT 2MM X 2CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·October 13, 2023
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 15, 2022
GALAXY G3 XSFT 2MM X 2CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014