9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Skin Care Beauty Mask (Model: MJ-06)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Smith & Nephew, Inc.·03596010103895·SUTURE WIRE 18 GA
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
LULLABY LED PHOTTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014
1188 HD CAMERA CONTROL UNIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FWB·August 15, 2011
FORTIFY ASSURA DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·February 23, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025