20 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PROCEED SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0600130·Tray Insert 3, Cosmolock Deformity
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575425716·Orthopaedic prosthesis instrument, reusable - G...
BAY AREA HYPERSCIENCES
FDA 510(k)
FDA Class 2
·Anesthesiology
MS-30 LATERAL FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·July 26, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 26, 2019
UNKNOWN NOTTINGHAM SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBF·May 17, 2017
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·August 21, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·April 24, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·October 3, 2019
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·April 5, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code LFR·June 10, 2008
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·August 23, 2019
COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·March 28, 2019
ULTRASAFE X100L PR GREY SSL SDZ
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 11, 2019
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018
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