123 results · 36ms · Sources: EU EUDAMED, US FDA

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Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925032002·SHEA PARASOL VENT TUBE 1 MM I.D. SILICONE

LCP

FDA UDI
Synthes GmbH·10886982164438·4.5MM LCP PROXIMAL TIBIA PLATE 4 HOLES/82MM-RIGHT

OsteoMed

FDA UDI
OSTEOMED LLC·00845694007566·76mm x 76mm Mesh Plate

rematitan®

FDA UDI
DENTAURUM GmbH & Co.KG·J011240036000·rematitan® attachment Activating screw

PIUR tUS Infinity

FDA 510(k)
FDA Class 2 ·Radiology

Trilogy®

FDA UDI
Zimmer, Inc.·00889024119260·

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER

Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

FDA Pre-Market Approval
FDA Class 3 ·eCoin Peripheral Neurostimulator

VARIPULSE¿ BI-DIRECTIONAL CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code QZI·May 21, 2026

IAB: 7.5 FR - 40 CC

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DSP·November 3, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 8, 2011

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·July 11, 2013

TRUPULSE¿ GENERATOR

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code QZI·December 1, 2025