36 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
Integra®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780251248·Replacement Fiber Optic Bifurcated Cable for th...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100258·EVOS Straight HA PEEK 9mm x 9mm x 26mm Biconvex...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0830090·Persuader, Rod Reduction, Kerrison Type
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080230090·30mm x 9mm Non-Lordotic Spacer
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197470810·Farrior Specula, oval
Ø 8.3x...
BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2
FDA 510(k)
FDA Class 2
·Dental
BRACE EZE
FDA 510(k)
FDA Class 1
·Dental
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 30, 2025
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 31, 2025
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 30, 2025
Octane M
FDA UDI
Choice Spine, LP·10885862236425·
ANCILLARY, XENON ULTRALITE SWE
FDA Adverse Event
Malfunction
·INTEGRA BURLINGTON, MA, INC.·Product code FCW·December 26, 2013
ALLURA XPER FD
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 30, 2025
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·March 21, 2013
PULSE GEN MODEL 101
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 24, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code MMI·December 20, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 22, 2011