19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Temperature Probe
FDA 510(k)
FDA Class 2
·General Hospital
GM HELIX ACQUA IMPLANT,TI,5.0X16
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 16, 2018
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
FDA 510(k)
FDA Class 2
·Dental
CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
FDA 510(k)
FDA Class 2
·Radiology
GM HELIX IMPLANT 4.3X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 6, 2018
GM HELIX IMPLANT 4.3X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018
GM DRIVE ACQUA IMPLANT 3.5X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018
GM HELIX ACQUA IMPLANT 3.75X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·January 2, 2025
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·February 18, 2025
GM HELIX IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 29, 2018
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·September 12, 2024
GM HELIX ACQUA IMPLANT 3.5X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018
GM DRIVE IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 20, 2018
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 14, 2024
BD VENFLON¿ PRO SAFETY
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 4, 2023
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORP·Product code MVK·May 31, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011
NOVATION ELEMENT FEMORAL STEM, 12/14
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 19, 2014