15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTBURS
FDA 510(k)
FDA Class 1
·Dental
BROACH, FEMORAL, ACTERA, SIZE 12
FDA UDI
Conformis, Inc.·00810933031558·ACTERA FEMORAL BROACH SIZE 12
BIOSORBFX AND BIOSORBPDX MESH
FDA 510(k)
FDA Class 2
·Dental
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
FDA 510(k)
FDA Class 2
·Microbiology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 3, 2025
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
BIVONA AIRE-CUF NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 8, 2013
OPTIBOND FL
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 6, 2011
PHOENIX
FDA Adverse Event
Injury
·GAMBRO DASCO·Product code FII·July 11, 2008
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 9, 2025
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014