11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Senhance Ultrasonic System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011824210·
EMG SUCTION UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTSUITE HEMODYNAMICS 7.10
FDA 510(k)
FDA Class 2
·Cardiovascular
MOBILELINK ACETABULAR CUP SYSTEM
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code LPH·February 20, 2025
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 24, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
PULSE GEN MODEL 100
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·June 21, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014