19 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176162038·Bone Cutter type 167 HP
THE AUTOTAC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EASYRA UREA NITROGEN AND CREATININE REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CADD SOLIS VIP PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTL·September 23, 2015
PELVICOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·April 10, 2013
M3155 RELEASE L.0 UPGRADE
FDA Adverse Event
Death
·PHILIPS HEALTHCARE·Product code MHX·May 27, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 13, 2008
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022
MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code FTL·August 8, 2014
¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTL·November 30, 2015
PREMILENE 3/0 (2) 75CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025