14 results
·
74ms
·
Sources: EU EUDAMED, US FDA
ID NOW COVID 19 ASSAY
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 29, 2021
MAMMOTOME ELITE PROBE
FDA Adverse Event
Malfunction
·DEVICOR MEDICAL PRODUCTS, INC·Product code KNW·November 21, 2016
MAMMOTOME ELITE PROBE
FDA Adverse Event
Malfunction
·DEVICOR MEDICAL PRODUCTS, INC·Product code KNW·January 31, 2017
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·December 10, 2021
Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4690-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code MMP·March 29, 2006
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
Lotus NL B.V.
Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices
Luxus Lebenswelt GmbH
Authorized representative
🇩🇪 Germany·191 Manufacturers·2068 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices