500 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SEMI-TUBULAR PLATE, 17-HOLE
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665029017·
n/a
FDA UDI
Ortho Development Corporation·00822409074709·12/14 Centralizer Trial 17mm
Encompass Hip Stem
FDA UDI
Ortho Development Corporation·00822409011926·17mm Distal Centralizer
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
FDA 510(k)
FDA Class 2
·General Hospital
MEDX 1000 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE ASSAY
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 19, 2013
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 15, 2011
SUMMIT TORQUE LIMITING DRIVER
FDA Adverse Event
Malfunction
·DEPUY SPINE, INC.·Product code LXH·June 11, 2008
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026