128 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIGHT BOND (QUICK CURE)
FDA 510(k)
FDA Class 2
·Dental
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001048·artVeneer life upper anteriors, IM, A2
TheraFlo M-set 42'' × 84'' QLT Recover
FDA UDI
Tridien Medical·00841965103784·TheraFlo M-set 42'' × 84'' QLT Recover
JBC
FDA UDI
FOREMOUNT ENTERPRISE CO., LTD.·04719871892275·Tracheal HME
TruFlex™
FDA UDI
Ortho Organizers, Inc.·00190707126827·TRUFLEX NiTi Thermal Upper 19x25 (10pk)
TruFlex
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730015075·NiTi Thermal Upper 19x25 10 archwires per pack
TheraFlo Cover 54'' × 80'' QLT Sen-1p
FDA UDI
Tridien Medical·00841965103937·TheraFlo Cover 54'' × 80'' QLT Sen-1p
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF20010480·2.4mm Cannulated Screw, Self Drilling, Short Th...
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
FDA 510(k)
FDA Class 2
·General Hospital
RGP MULTI-PURPOSE SOLUTION ID 100136
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·January 31, 2018
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 13, 2013
UNKNOWN ZIMMER MIS TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·February 21, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·February 22, 2008
BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD·Product code QKP·April 28, 2023
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD·Product code QKP·April 28, 2023
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD·Product code QKP·April 28, 2023
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD·Product code QKP·April 28, 2023
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD·Product code QKP·April 28, 2023