32 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE
FDA 510(k)
FDA Class 2
·General Hospital
Lieberman Speculum
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896109131·Lieberman Speculum Temporal Approach 14 Millime...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111376399·INSTRU TRAY 12.75 X 10.5 X 4
Moda-flx Hemodialysis System
FDA UDI
Diality Inc·00860008016928·Moda-flx Disposable Cartridge
Sklar®
FDA UDI
SKLAR CORPORATION·30649111379790·INST TRAY 12.75X10 3/8X4 PK 6
Sklar
FDA UDI
SKLAR CORPORATION·30649111328354·INSTR TRAY 123/4X103/8X4 INCHESPK/12
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365106958·
PALOMAR LC 100 DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·May 6, 2021
FUJIFILM DUODENOSCOPE MODEL ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·September 5, 2023
FUJIFILM ENDOSCOPE
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDS·March 18, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2024
FUJIFILM DUODENOSCOPE ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·March 5, 2025
DUAL MOBILITY VIVACIT E BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 6, 2024
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 9, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·May 25, 2011
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 7, 2008
VIVACIT-E DM BEARING 28X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 28, 2023
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025