20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endoscopy Oxygen Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
MediBag
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005862·MediBag- 100 mL Dual Port (Needless and Spike P...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506084676·LAVAGE CANNULA WITH 3-WAY STOPCOCK, POOLE SUCTI...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776155933·ASP LAVAGE CANNULA LARGE
JEDMED
FDA UDI
JEDMED INSTRUMENT COMPANY·M6332205330·HOOK FIXATION DOUBLE GUTHRIE
TriVerse Femoral Sizer Paddles
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097325·
EXEL VACULET BLOOD COLLECTION SET
FDA 510(k)
FDA Class 2
·General Hospital
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROLET®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026
MICROLET®
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 3, 2025
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 18, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·November 3, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
MICROLET®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code QRL·July 1, 2025
MICROLET®
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code QRL·December 1, 2023
BD Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·January 12, 2024
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 25, 2018
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 7, 2018
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·February 15, 2018
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021