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