18 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NOVA Lite DAPI dsDNA Crithidia luciliae Kit
FDA 510(k)
FDA Class 2
·Immunology
VERSANT CHELSEA MORGAN
FDA UDI
FGX INTERNATIONAL INC.·00193033308202·
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025
G-CATH TISSUE ANCHOR DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025
FUJIFILM ENDOSCOPE MODELS EC-760R-V/M
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·March 25, 2024
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 27, 2013
WECK HEMOLOK ML CLIPS 6/CART 84/BOX
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·July 22, 2011
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016