21 results
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73ms
·
Sources: EU EUDAMED, US FDA
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleural space.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
EVIS EXERA II DUODENOVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·April 1, 2021
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 14, 2018
EVIS LUCERA COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·January 4, 2023
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC.·Product code FPA·March 30, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code HBC·March 26, 2018
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleural space.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code JOL·June 11, 2024
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
GUANGZHOU LEAD FAIR PLASTIC CO., LTD.
FDA registration
GUANGZHOU LEAD FAIR PLASTIC CO., LTD.·3 products·🇨🇳 China
Advena Services Limited
Importer
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Aesthetic Group
Importer
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SUNGO Europe B.V.
Authorized representative
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RIOMAVIX LTD
Authorized representative
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Humiss Beratung GmbH
Authorized representative
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Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
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Lotus NL B.V.
Authorized representative
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MedPath GmbH
Authorized representative
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PANSIPROD DISTRIBUTIE
Importer
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CEpartner4U
Authorized representative
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