14 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Dental
Safco T&F Bur - 12 Bladed
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72327920033·Safco T&F bur - 12 bladed, carbide, #7006 round...
Helix
FDA UDI
Nuvasive, Inc.·00887517969095·Helix-R Screwdriver, Large No Spin Cap
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470004472·PERC DLR SPINE WAND SURGICAL DEVICE
Continuum® Trilogy® IT Allofit® IT Acetabular Systems
FDA UDI
Zimmer, Inc.·00889024152762·
Auxein Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
FDA 510(k)
FDA Class 2
·Anesthesiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2014
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 12, 2012
TRILOGY 202
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS·Product code CBK·May 22, 2015
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
FDA Recall
Terminated
·Orthofix, Inc·Product code NKG·February 23, 2018
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
FDA Enforcement
Class II
·Terminated·Orthofix, Inc·April 18, 2018
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
FDA Enforcement
Class II
·Terminated·Orthofix, Inc·April 18, 2018
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
FDA Recall
Terminated
·Orthofix, Inc·Product code NKG·February 23, 2018