18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PIUR tUS Infinity
FDA 510(k)
FDA Class 2
·Radiology
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
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·OmniaSecure MRI SureScan Lead Model 3930M
INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
FDA 510(k)
FDA Class 2
·General Hospital
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
FDA 510(k)
FDA Class 2
·Cardiovascular
Trilogy®
FDA UDI
Zimmer, Inc.·00889024119260·
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
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