15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MERIT SAFETY INTRODUCER NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
Starbond Easy
FDA UDI
S & S Scheftner GmbH·04260207854226·Disc, 13,5 mm ø 98,3 mm / with edging
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191360·Patella Resection Cover Size 35
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319740729·Non-Perforating Towel Clamp 5-1/4" (13.1cm)
icotec Cervical Cage, Anatomic Probe, 5 mm x 13 mm
FDA UDI
icotec AG·07640140433813·icotec Cervical Cage, Anatomic Probe, 5 mm x 13 mm
VOLISTA 400; VOLISTA 600
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLOW BY ENDYMED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 16, 2023
EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSD·June 19, 2023
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014
HAKIM INLINE PROGRAMMABLE VALVE SG
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·May 31, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 27, 2011
BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR
FDA Adverse Event
Injury
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·October 28, 2020
GALAFLEX
FDA Adverse Event
Injury
·TEPHA, INC·Product code OOD·February 28, 2020
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·June 11, 2014