10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SERISCAFFOLD SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2024
QUATTRODE LEAD WIDE SPACED, 90 CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·August 16, 2023
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 1, 2019
OT SELECT METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 26, 2013
PENUMBRA SYSTEM REPERFUSION CATHETER 041
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·April 22, 2011
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 24, 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