17 results · 22ms · 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.

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

REMEL

FDA UDI
REMEL, INC.·00848838023088·Nitrocefin Disk 25Disk/VL

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

HORIZONS INTERNATIONAL POLYPECTOMY SNARES

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

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 25, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSD·October 12, 2023

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 14, 2025

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·July 15, 2025

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 29, 2014

SCREWDRIVER BLADE, T7, AO

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·August 6, 2011

CONTAK RENEWAL

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 14, 2025

NC QUANTUM APEX?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 26, 2026

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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