14 results · 29ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

THE BELMONT BUDDY LITE FLUID WARMER

FDA 510(k)
FDA Class 2 ·Hematology

9300

FDA UDI
HANS RUDOLPH, INC.·00874750009275·9351 INSP OCCL SUB W/1410

SE-300 VACUUM THERAPY SYSTEM

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

SL3

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

POLYMOBIL PLUS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026

U BY KOTEX SLEEK

FDA Adverse Event
Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

UNKNOWN DEPUY S ROM STEM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 19, 2011

ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR.THIN) - 35 MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 11, 2008

U BY KOTEX SLEEK

FDA Adverse Event
Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

MOBILETT ELARA MAX

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025