19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medtronic Model 5392 External Pulse Generator (EPG)
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DTE·February 10, 2021
AGXO
FDA UDI
Oticon A/S·05707131286215·H160V2 TI, RITE 312 WL STG AGXO
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120588·Guidewire 2.4x150mm Sgl Trocar
Patella Trial Size 1
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074111·
3 ML BD LUER-LOK LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 1, 2020
BD LUER-LOK TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 17, 2020
3 ML BD LUER-LOK LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 26, 2020
MAX-IF1000
FDA 510(k)
FDA Class 2
·Neurology
SIS DERMAL AUGMENTATION STRAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD 3 ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·August 19, 2020
3 ML BD LUER-LOK LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 25, 2020
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 3, 2024
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 29, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 10, 2011
SYNERGY
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LGW·September 3, 2008
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·August 20, 2021
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013