15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
FDA 510(k)
FDA Class 2
·Dental
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017736·K-Wire, Double Ended, Trocar Point, Diameter Si...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052528·Leriche Hemostatic Forceps
1x2 te...
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Dental
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
FDA 510(k)
FDA Class 2
·Cardiovascular
PINN MAR +4 10D 28IDX46OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 7, 2024
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 31, 2013
SYNCHRON UNICEL DXC 600
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·June 27, 2011
ENDO GIA II 60-3.5 SULU
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·August 29, 2008
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017