15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FILTEK BULK FILL POSTERIOR RESTROATIVE
FDA 510(k)
FDA Class 2
·Dental
MAGNUM INSTRUMENTATION
FDA UDI
Biomet Uk Ltd·05019279440412·
M2a-Magnum™
FDA UDI
Biomet Orthopedics, LLC·00887868474361·
CYBER TM FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015
Widex
FDA UDI
Widex A/S·05706069812596·Widex EVOKE E-PA (Tan silk ) 440, RC coil
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 3, 2014
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 3, 2013
ENDEAVOR RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 21, 2011
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
FDA Enforcement
Class II
·Terminated·AMS Diagnostics, LLC·April 2, 2014
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
FDA Enforcement
Class II
·Terminated·AMS Diagnostics, LLC·April 2, 2014