12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sunmed Haemostatic Valves
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100592·LIEBERMAN TEMPORAL SPECULUM V-WIRE
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 16, 2025
ELECSYS 2010 DISK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 17, 2010
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHS·November 20, 2009
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 7, 2011
REVEAL XT
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DSI·June 8, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008
ALARIS SYSTEM
FDA Adverse Event
Injury
·CAREFUSION SD·Product code FRN·April 26, 2023
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023