21 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
FDA 510(k)
FDA Class 2
·Radiology
RENEGADE STC 18 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GLADIATOR PTA BALLOON DILATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970720·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970737·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970744·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973387·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970706·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970713·
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025
GLADIATOR¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 6, 2012
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
UNKNOWN DEPUY BONE CEMENT
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·May 22, 2013
EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code GWM·September 26, 2014
CAROTID SHUNT 11FR. SIL.BALLOON W/CHECKVALVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·June 14, 2011
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
LOGIC CR FEMORAL POR, RIGHT, SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 14, 2019
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024