10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TCL3 Motion Tracking System
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Brain Heart Infusion with 6.5% Sodium Chloride
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902217856·BD BBL™ Brain Heart Infusion with 6.5% Sodium C...
SCEPTER C OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EPIEN Dental Cleanser
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
SCEPTER XC
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code DQY·December 6, 2023
VISINE FOR CONTACTS
FDA Adverse Event
JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES·Product code LPN·October 1, 2008
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·August 17, 2011
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·July 9, 2013
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 26, 2019