19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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E-CUBE 15
FDA 510(k)
FDA Class 2
·Radiology
ASSI
FDA UDI
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION·00841645119272·Fomon Rasp, 21cm Double Ended,Str., TC Ends 7mm...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011123610000·Hard metal burs, mini, Form: conical, domed end
Cook
FDA UDI
COOK INCORPORATED·00827002165632·Rectal Pressure Catheter
ANA-SCREEN WITH MDSS
FDA 510(k)
FDA Class 2
·Immunology
CLEARVIEW EXACT II INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
INSYTE AUTOG BC WING PNK 20GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·December 11, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 6, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 7, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 6, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 7, 2024
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 6, 2024
AJUST ADJUSTABLE SINGLE INCISION SLING
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code PAH·May 17, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 26, 2014
INS SAF SYR 1CC 29X1 / 2IN
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMF·June 10, 2011
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
BD INSYTE AUTOGUARD BC WING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 7, 2024
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
INTIMA II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 31, 2018