15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 19, 2025
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FREEZER TEETHER
FDA 510(k)
FDA Class 2
·Dental
PASS LP
FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 29, 2013
SD/PD LONG CURVED
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·April 26, 2011
4.0MM CANNULATED SCREW LONG THREAD/46MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWC·July 23, 2008
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 17, 2018
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 22, 2020
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