18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACHILLES
FDA 510(k)
FDA Class 2
·Radiology
SBH
FDA UDI
SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...
Unity Total Knee System
FDA UDI
CORIN LTD·05055343897898·Tibial Augment 5mm RL-LM size 9
Extension Panel - Zynex Pro Hybrid LSO 637
FDA UDI
Manamed, Inc.·00810113683072·The Zynex Pro Hybrid LSO 637 is a universal sac...
ArgenPMMA 98x30-B2
FDA UDI
ARGEN CORPORATION, THE·D818123238·Crown And Bridge, Temporary, Resin
MCPULSE
FDA 510(k)
FDA Class 2
·Cardiovascular
1.5T OPTIMA MR430S
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 22, 2024
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 21, 2013
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MAF·September 26, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 14, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
HEMOCONCENTRATOR BC 20 PLUS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016
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