20 results
·
41ms
·
Sources: EU EUDAMED, US FDA
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·October 24, 2012
VITROS XT 7600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·February 18, 2026
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JGS·August 24, 2023
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JGS·November 26, 2024
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JIX·May 13, 2026
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JGS·April 18, 2024
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JIX·February 13, 2026
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One Time Use, Contents 4 sets 1-guide rod, 23 mm, 250 mm long, dilating. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalgo ref. 4-12GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 12mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-10GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 10 mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-15GPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 15 mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DGPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 23 mm, 250 mm long, dilating. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Sharkmed Oy
Importer
🇫🇮 Finland·18 Manufacturers
CEpartner4U
Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
Lotus NL B.V.
Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices