15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ID NOW Influenza A & B 2
FDA 510(k)
FDA Class 2
·Microbiology
Orthos
FDA UDI
ORMCO CORPORATION·00889989029864·ORTHOS CM CUNITI 27ARCH 18DIAUPSMPK10
Cascade
FDA UDI
CADWELL INDUSTRIES, INC.·00840067100417·ES5-20 Stim Splitter
UniTip Catheter
FDA UDI
Unisensor AG·07640172971956·
BRAINLAB TRAUMA
FDA 510(k)
FDA Class 2
·Neurology
SONALIS
FDA 510(k)
FDA Class 2
·Radiology
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
LASIK SURGERY
FDA Adverse Event
Injury
·Product code LZS·October 6, 2008
PALINDROME HSI 28/45 KIT VT CE
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MPB·June 10, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 4, 2011
EXPRESSEW III W/O HOOK
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code LXH·October 26, 2021
EXEL HYPO NDL 27GX1-½"
FDA Adverse Event
Injury
·EXELINT INTERNATIONAL, CO.·Product code FMF·April 17, 2024
EXOGEN Ultrasound Coupling Gel
FDA Enforcement
Class II
·Terminated·Bioventus, LLC·January 20, 2021
STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 16, 2023