15 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179376·
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 6, 2024
Rebar
FDA UDI
Micro Therapeutics, Inc.·00836462002135·105-5080-153 REBAR-14 153CM
RebarTM
FDA UDI
Micro Therapeutics, Inc.·00847536026773·MICRO CATH 105-5080-153 V01 REBAR
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024377554·ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH...
CONSENSUS ACETABLAR SHELL, TI COATED
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHRO-SURGIMAT-A103
FDA 510(k)
FDA Class 2
·Orthopedic
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 16, 2023
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·October 21, 2024
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·December 4, 2024
EPIC II PLUS HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·April 26, 2013
S-ROM LINERS M28 15DEG, 28MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 18, 2008
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 6, 2011
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