17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOVIX DReamy
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ TB Auramine-Rhodamine T
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902125151·BD BBL™ TB Auramine-Rhodamine T, 4 x 250 mL
Philips
FDA UDI
Sbo Hearing A/S·05714464003471·HEARLINK 9010 MNR, 2.4G NFM PB BL
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365115530·
BIFURCATED VACCINATING NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
PENCAN SPINAL NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
OVERJET CARIES ASSIST
FDA Adverse Event
Malfunction
·OVERJET·Product code MYN·February 18, 2025
EPIC¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·August 16, 2011
MONOPOLAR CURVED SCISSORS ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·October 27, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023