12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604923·BERCHTOLD B810, B710 5.25" SOFTCARE PLUS
CUSTOME KIT, CT-SET
FDA Adverse Event
Malfunction
·MERIT MEDICAL IRELAND, LTD.·Product code FPA·September 11, 2006
AUDIOSCREENER OAE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CHESS HAND SURGERY SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·August 13, 2025
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·August 13, 2025
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
CONTINUUM TRILOGY IT LONGEVITY POLY LINER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JDI·April 7, 2011
PALMAZ GENESIS OPTA PRO
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code FGE·July 21, 2008
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016
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