26 results
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24ms
·
Sources: EU EUDAMED, US FDA
bite away neo
FDA 510(k)
FDA Class 2
·Physical Medicine
LEONE SPA
FDA UDI
LEONE SPA·08033707022411·CALIBRA BANDS 2ND MOLAR n.SUR 14
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540355721·Locking Screws, Cross-Pin
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113317·PS Insert, Size 5 x 14mm
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220514000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220514070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220514150·
CARDIOPACS
FDA 510(k)
FDA Class 2
·Radiology
PULPDENT GLAZE II
FDA 510(k)
FDA Class 2
·Dental
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 18, 2011
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH LTD./HUNTINGTON·Product code MJP·October 29, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
BD CATHENA¿ SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 7, 2022
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 22, 2024
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019