21 results · 73ms · Sources: EU EUDAMED, US FDA

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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
🇲🇹 Malta·40 Manufacturers

Aesthetic Group

Importer
🇫🇷 France·11 Manufacturers

SUNGO Europe B.V.

Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

RIOMAVIX LTD

Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices

Humiss Beratung GmbH

Authorized representative
🇩🇪 Germany·152 Manufacturers·925 Devices

Shanghai International Holding Corp. GmbH(Europe)

Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices

Lotus NL B.V.

Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices

MedPath GmbH

Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices

PANSIPROD DISTRIBUTIE

Importer
🇷🇴 Romania·21 Manufacturers

CEpartner4U

Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices