166 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Alpen Carbides
FDA UDI
Dent4You AG·07630392906012·Alpen Carbides 1170-FG-1.00-4.10, 10 pcs
Fathom
FDA UDI
Seaspine Orthopedics Corporation·10889981300258·Retractor Base Rack, 170mm
Taperloc Complete Primary Femoral
FDA UDI
Biomet Orthopedics, LLC·00880304499157·
Zavation
FDA UDI
Zavation LLC·00197157009779·7.0mm TAP, CANNULATED
EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex®
FDA UDI
ARTHREX, INC.·00888867523371·DILATOR, 10.1 X 170MM
VIDAS TSH 60 TESTS
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·September 4, 2020
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 15, 2026
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 30, 2025
BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·January 19, 2022
BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·January 6, 2022
BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·January 27, 2022
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 24, 2015
ELLIPSE DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013
S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) MOLDABLE WAFER
FDA Adverse Event
Injury
·CONVATEC, INC·Product code EXE·September 17, 2014
BD SYRINGE¿ 3ML LL W/NDL ECLIPSE¿ 22X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·March 29, 2019
BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·June 25, 2019
GMK-REVISION FEMUR REVISION PS SIZE 1 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 11, 2020