19 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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Jac-Cell Medic testers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780130468·POOLE ABDOMINAL SUCTION TUBE WITH CONTROL VALVE
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168803·CORTICAL SHANK, Cannulated, 7.0 X 105
MESA® Spinal System
FDA UDI
VB Spine LLC·10888857232471·MESA 2 Deformity 360° Screw Size Ø7.0x105 mm
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168807·CORTICAL SHANK, Cannulated, 7.0 X 105
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
PHILIPS SONICARE
FDA Adverse Event
Injury
·PHILIPS ORAL HEALTHCARE·Product code JEQ·December 7, 2017
MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 16, 2024
MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK SPHERE- LEFT - SIZE6+
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018
630G INSULIN PUMP MMT-1715K 630G BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 25, 2018
MINILINK TRANSMITTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·October 14, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 14, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 20, 2011
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR INC.·Product code MGB·March 8, 2006
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
VERSAFITCUP CC TRIO 01.26.3244STT FLAT PE LINER 32 / E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 23, 2021