15 results · 24ms · Sources: EU EUDAMED, 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