30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO CD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sledgehammer
FDA UDI
Keystone Industries·H66810004761·HC 25 lb Pwd & 4 Qt Liq Kit, Lt Reddish Pink
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116487·NobelBiocare™ Tri-Lobe-compatible NP Straight M...
Zavation
FDA UDI
Zavation LLC·00842166122178·4-Level, 76mm Cervical Plate
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004760·
PenEvac1
FDA UDI
I.C. MEDICAL, INC.·00817688020240·
CURE ACP
FDA UDI
SpineArt SA·07640270065717·ANTERIOR CERVICAL PLATE, 4 LEVELS L76
CELL-CHEX
FDA 510(k)
FDA Class 2
·Hematology
MPT 24 AND VITAL VIEW 24
FDA 510(k)
FDA Class 2
·Cardiovascular
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640375231703·CERVICAL 4 LEVEL TEMPLATE L76
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004760·
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640375234124·ANTERIOR CERVICAL PLATE, 4 LEVELS L76
OPTIMIZER POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code FDI·August 23, 2016
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code DHA·November 6, 2011
UNKNOWN DEPUY DEVICE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 12, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 16, 2011
ZENITH RENU CONVERTER AAA ANCILLARY GRAFT
FDA Adverse Event
Injury
·COOK INCORPORATED·Product code MIH·February 21, 2008
OPTIMIZER POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT COMPANY·Product code FDI·July 16, 2016
OPTIMIZER® POLYPECTOMY SNARE, SMALL (MINI) OVAL
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT COMPANY·Product code FDI·July 7, 2016
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015