20 results
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20ms
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Sources: EU EUDAMED, US FDA
TROPIC AIR HEAT-ECHANGER BREATHING AID
FDA 510(k)
FDA Class 2
·Anesthesiology
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780518372·CODMAN® Clear Ventricular CSF Catheter Kit
CODMAN EDS 3
FDA UDI
Cerenovus, Inc.·10886704040941·CODMAN EDS 3 Clear Ventricular CSF Catheter Inc...
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268217350·CUSTOM SURGICAL KIT VEIN PACK
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268217351·CUSTOM SURGICAL KIT VEIN PACK
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M7526821735R10·CUSTOM SURGICAL KIT VEIN PACK
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FIBER DISK AND BLOCK PERMANENT, TRINIA
FDA 510(k)
FDA Class 2
·Dental
EDS3 CLEAR VENT CATH
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·October 19, 2023
EDS3 CLEAR VENT CATH
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·May 28, 2025
CODMAN EX. DRAINAGE VENTRICULAR CATH. SET
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./MEDOS S.A·Product code JXG·October 13, 2005
EDS3 CLEAR VENT CATH
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·February 21, 2025
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·May 20, 2014
ALUMINA HEAD
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code MRA·November 6, 2012
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 25, 2010
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
FDA 510(k)
FDA Class 2
·Neurology
CODMAN EXTERNAL DRAINAGE SYSTEM III
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·February 23, 2016
EXT DRAINAGE SYSTEM III WITHOUT VENT CATH
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF·Product code JXG·May 20, 2014
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021