14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOBLOC BM SERIES
FDA 510(k)
FDA Class 2
·Dental
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213036307·Coupling Treatment Tube for 6F Flexibles (26)
Depth gauge
FDA UDI
Jeil Medical Corporation·08800089475636·
Depth gauge
FDA UDI
Jeil Medical Corporation·08800089475629·
ACCUSCULPT II LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089475674·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089475667·
9CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·May 6, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
S-ROM LINR MSER, 0 DEG, 28MM C
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 13, 2011
BD PYXIS¿ ANESTHESIA STATION ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·July 17, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025