14 results · 20ms · Sources: EU EUDAMED, US FDA

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Biobeat Platform, BB-613WP Patch

FDA 510(k)
FDA Class 2 ·Cardiovascular

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM

CHESAPEAKE® Stabilization System

FDA UDI
VB Spine LLC·10888857082038·3-Screw Titanium Implant, Size 15x18x12 mm

Sapphire II Pro

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955942082·Balloon Dilatation Catheter

ONE TOUCH BASIC

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·January 10, 2002

LOWSLEY SUPRAPUBIC TRACTOR

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

IROOT 100 MINI

FDA 510(k)
FDA Unclassified ·Unknown

BD EMERALD¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 30, 2023

THERMACARE LOWER BACK & HIP (THERMACARE HEATWRAP) WRAP

FDA Adverse Event
Malfunction ·PFIZER CONSUMER HEALTH CARE·Product code IMD·July 8, 2011

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·July 8, 2013

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Model Number L211 PROPONENT DR SL MRI Pacemaker

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