47 results
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30ms
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Sources: EU EUDAMED, US FDA
HYSEN INC
FDA registration
HYSEN INC·22 products·🇺🇸 United States
HYSEN Fentanyl Rapid Test
FDA UDI
HYSEN INC.·00850076289034·HYSEN Fentanyl Rapid Test, 1 ng/mL
Hysen Drug Test Cards
FDA UDI
HYSEN INC.·10850076289017·Hysen Drug Test Cards
AMP1000/BAR300/BUP10/BZO3...
Hysen Drug Test Cups
FDA UDI
HYSEN INC.·10850076289055·Hysen Drug Test Cups
COC300/AMP1000/MET1000/THC...
Hysen Drug Test Cups
FDA UDI
HYSEN INC.·10850076289062·Hysen Drug Test Cups
AMP/BAR/BUP/BZO/COC/MET/MD...
Hysen Drug Test Cups
FDA UDI
HYSEN INC.·10850076289000·Hysen Drug Test Cups
AMP1000/BAR300/BUP10/BZO30...
HYSEN Multiple Drugs Test Cup
FDA UDI
HYSEN INC.·00850076289041·HYSEN Multiple Drugs Test Cup, AMP/500, BAR/300...
HYSEN Multi-Panel Drug Test Dip Card
FDA UDI
HYSEN INC.·00850076289027·HYSEN Multi-Panel Drug Test Dip Card, PCP /25, ...
Hysen Drug Test Cards
FDA UDI
HYSEN INC.·10850076289079·Hysen Drug Test Cards
COC300/MET1000/OPI2000/PC...
UNKNOWN RELOAD FOR ECHELON 60
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2021
SOFTWARE, PRAAS VERSION 2.0A
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PHV·December 7, 2023
Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
FDA Recall
Terminated
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021