38 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450054697·
MODIFICATION TO XIA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CALIBRATING MATERIAL, BUFFERS, STANDARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMPRA VASCULAR GRAFT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DSY·March 12, 2023
DISTAFLO BYPASS GRAFT
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DSY·August 2, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
BD MICROTAINER® QUIKHEEL¿ PREEMIE LANCET
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code FMK·July 11, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 26, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 21, 2008
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·June 11, 2024
IMPRA VASCULAR GRAFT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DYF·July 27, 2023
IMPRA VASCULAR GRAFT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DYF·July 27, 2023
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
FDA Enforcement
Class II
·Ongoing·C.R. Bard Inc·September 3, 2025
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
BD MICROLANCE¿3 NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 20, 2023
CLEARLINK/CONTINU-FLO/DUO-VENT
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 8, 2025
SYRINGE 20ML LL S/C 48
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·June 12, 2024