12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AESCULAP BIPOLAR ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
Trulife
FDA UDI
Trulife Limited·00645517726694·First Fit External Breast Form Size 07
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575428663·Orthopaedic prosthesis instrument, reusable - G...
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
FDA 510(k)
FDA Class 2
·Cardiovascular
LEICA COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code FTL·June 5, 2008
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Enforcement
Class II
·Terminated·Ondamed Inc·May 16, 2018