19 results · 25ms · Sources: EU EUDAMED, 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