18 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Small VBR
FDA 510(k)
FDA Class 2
·Orthopedic
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260636·
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304462885·
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032672·ET40, KIT 13 2.4G NFM L BE ENCHANT 40
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776199395·LLETZ BRAUN TENACULUM FORCEPS
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419099·Integra® Miltex® House Forceps, 3-1/4" Shaft, S...
BD TUBE PMS PLH 13X75 3.0 SLBL LIM CE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 25, 2023
TISSU TRANS FILTRON SYRINGE FILL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCENAR, MODEL 10
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 16, 2023
BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 8, 2023
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 2, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·October 7, 2008
BIPAP S/T C SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code MNS·June 20, 2013
ATTAIN ABILITY
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 4, 2011
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026