41 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
TEWA
FDA UDI
asia-med GmbH·04251282508531·TeWa 5CB-Type 1840 Speed Pak: coated acupunctu...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501211·TeWa 5CB-Type 1840 Speed Pak: coated acupunctu...
GeneXpert Dx System
FDA UDI
CEPHEID·07332940006730·XPERT, GENEXPERT DX SYSTEM
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
FDA 510(k)
FDA Class 2
·Cardiovascular
Clarity®
FDA UDI
Elekta Solutions AB·07540180000160·Clarity® Calibration & QA Phantom
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 14, 2024
FlowLogic Agile
FDA UDI
SONENDO, INC.·00810209421151·FlowLogic Agile Shaping File Variable Kit, 25mm
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129681·ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,MEDIUM
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522131356·ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,MEDIUM,UKCA
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 14, 2024
MFCD 118
FDA 510(k)
FDA Class 2
·Radiology
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·August 19, 2013
MITEK EXPRESSEW III NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code LXH·March 12, 2013
ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE)
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 18, 2011
PFC SIG RPF INS SZ 3 10 MM
FDA Adverse Event
Injury
·DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·February 19, 2008
BD ALARIS¿ ASSEMBLY NAC Y-SITE TUBING
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 8, 2022
MILEX
FDA Adverse Event
Death
·COOPERSURGICAL, INC.·Product code HHW·May 27, 2025
BD ASSEMBLY NAC-Y SITE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·December 12, 2023