24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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chromID Strepto B agar
FDA 510(k)
FDA Class 1
·Microbiology
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
Aquila Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125806·
Pinehurst Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030742·
ATMOS E 201 THORAX AND ATMOS S 201 THORAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIOMEM CM 3000-12BT
FDA 510(k)
FDA Class 2
·Cardiovascular
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024
1030489-2019-01511
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·May 28, 2013
VIVA QUAD XT
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014
1030489-2019-01423
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·September 8, 2021
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 22, 2022
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·January 16, 2020