15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA LITE H-TTG/DGP SCREEN
FDA 510(k)
FDA Class 2
·Immunology
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 6, 2025
TruLock
FDA UDI
Rmo, Inc.·00885797644947·TRULOCK Primer Activated Adhesive Mini Kit (1ea...
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959043749·ComfortGel Blue Nasal Mask w/Headgear, Medium, ...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114694933·Osteotome for Ø4.2mm Implant
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694383·LOCATOR Abutment Internal Hex. SP H2mm
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108691955·Osteotome for Ø4.2mm Implant
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
FDA 510(k)
FDA Class 2
·Cardiovascular
EBI XFIX DFS RAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 25, 2025
STERNAL ZIPFIX WITH NEEDLE STERILE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JDQ·April 22, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 26, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020