14 results · 24ms · Sources: EU EUDAMED, US FDA

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Disposable Endoscope Valve Sets

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026

PERICAM PSI

FDA 510(k)
FDA Class 2 ·Cardiovascular

EXCELLITE LIGHT CURE UNIT

FDA 510(k)
FDA Class 2 ·Dental

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026

KIT IMPLANTABLE SLIM TIP LEAD, 50CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code PMP·July 8, 2024

BD POSIFLUSH

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026

BD POSIFLUSH

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·October 29, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011

AMX 700 CX

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code JCW·July 8, 2013

BD CATHENA¿ SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 7, 2022

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018