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Datascope Corporation

35 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic bal recall (Z-0131-2023)Datascope Corporation2022-10-24
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter recall (Z-1685-2022)Datascope Corporation2022-09-08
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter recall (Z-1686-2022)Datascope Corporation2022-09-08
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter recall (Z-1687-2022)Datascope Corporation2022-09-08
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0 recall (Z-2831-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295- recall (Z-2832-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, recall (Z-2833-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-04 recall (Z-2834-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-047 recall (Z-2835-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 068 recall (Z-2836-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-0 recall (Z-2837-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478 recall (Z-2838-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479 recall (Z-2839-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480 recall (Z-2840-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 068 recall (Z-2841-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Us recall (Z-2842-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P recall (Z-2843-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P recall (Z-2844-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/ recall (Z-2845-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/ recall (Z-2846-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/ recall (Z-2847-2020)Datascope Corporation2020-08-21
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon cath recall (Z-1383-2018)Datascope Corporation2018-04-16
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon cath recall (Z-1384-2018)Datascope Corporation2018-04-16
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon cathet recall (Z-1385-2018)Datascope Corporation2018-04-16
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 Th recall (Z-1769-2017)Datascope Corporation2017-03-23
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group recall (Z-2568-2014)Datascope Corporation2014-09-03
CS100 Intra-Aortic Balloon Pump. recall (Z-1811-2010)Datascope Corporation2010-06-21
CS300 Intra-Aortic Balloon Pump recall (Z-1812-2010)Datascope Corporation2010-06-21
System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Ho recall (Z-1813-2010)Datascope Corporation2010-06-21
Low-Level Output Cable. The device is used to allow the information displayed on the Intra recall (Z-1198-2009)Datascope Corporation2009-04-15
Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1 recall (Z-0150-2008)Datascope Corporation2008-01-17
Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The ki recall (Z-1156-2007)Datascope Corporation2007-08-09
The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, recall (Z-1157-2007)Datascope Corporation2007-08-09
Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device. Ma recall (Z-1158-2007)Datascope Corporation2007-08-09
HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Ca recall (Z-0638-04)Datascope Corporation2004-07-20

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Every clearance here is in the API, with alerts when new ones post.