17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ClearTip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD BBL™ Sensi-Disc™ Bacitracin 2 units
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312674·BD BBL™ Sensi-Disc™ Bacitracin 2 units
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022700·Dornier 400 µm Single-Use SMA Diode Laser Fiber...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111162831·SKLARCUT SKLARLITE METZ CVD 7"
STERICHEK BICARB PH REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011
LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·July 17, 2013
UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025
BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025