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Panels › Gastroenterology, Urology › Product code MSB · Class 2

System And Accessories, Isolated Heart, Transport And Preservation

Regulation 876.5880

1510(k)s in 12 months (14 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in MSB

Company510(k)sRecalls
Paragonix Technologies50
TransMedics, Inc.20
Vitrolife AB11
Vitrolife Sweden AB20
Dr. Franz Kohler Chemie GmbH10
INSTITUT GEORGES LOPEZ01
S.A.L.F. Spa10
Sangstat Medical Corp.10
Traferox Technologies, Inc.10
Decided510(k)Device and applicantCode
Sep 16, 2026K261913X°Port Heart Preservation System
Traferox Technologies, Inc., CA
MSB
Nov 18, 2022K222535OCS Lung Donor Flush Set
TransMedics, Inc.
MSB
Jul 29, 2021K211314OCS Lung Solution
TransMedics, Inc.
MSB
Aug 14, 2019K190063Servator C SALF Solution
S.A.L.F. Spa, IT
MSB
Oct 19, 2018K182735Paragonix SherpaPak Cardiac Transport System
Paragonix Technologies
MSB
Mar 30, 2018K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Paragonix Technologies, Inc.
MSB
Nov 25, 2014K143074Sherpa Pak Cardiac Transport System
Paragonix Technologies, Inc.
MSB
Feb 21, 2014K133432SHERPA PAK CARDIAC TRANSPORT SYSTEM
Paragonix Technologies, Inc.
MSB
Feb 6, 2013K123326SHERPA PAK CARDIAC TRANSPORT SYSTEM
Paragonix Technologies, Inc.
MSB
Oct 9, 2008K081997PERFADEX WITH THAM
Vitrolife Sweden AB, SE
MSB
Apr 5, 2004K032794CUSTODIOL
Dr. Franz Kohler Chemie GmbH
MSB
Oct 27, 2003K022730PERFADEX SOLUTION FOR LUNG PRESERVATION
Vitrolife AB
MSB
Mar 8, 2001K000881PERFADEX SOLUTION FOR ORGAN PRESERVATION
Vitrolife Sweden AB
MSB
Aug 5, 1999K991594CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
Sangstat Medical Corp.
MSB

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