9 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Triumph Resin Dam
FDA 510(k)
FDA Class 1
·Dental
NEODENT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MIOT PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2021
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
DRAEGER APOLLO
FDA Adverse Event
Other
·NORTH AMERICAN DRAEGER·Product code BSZ·September 5, 2008
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014