6 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ReWalk Personal 6.0. Catalog number: 50-20-0004.
FDA Recall
Terminated
·Argo Medical Technologies Ltd Matambuilding 30p.O.Box·Product code PHL·August 14, 2017
ReWalk Personal 6.0. Catalog number: 50-20-0004.
FDA Enforcement
Class II
·Terminated·Argo Medical Technologies Ltd·March 21, 2018
DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, muscular-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·February 26, 2020
Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
FDA Enforcement
Class II
·Terminated·Sonesta Medical Ab·May 10, 2017
DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, muscular-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code IYN·January 13, 2020
Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brilliance 16, M/Ns 5001-6180, 50002-50139 ; Brilliance 16P, M/Ns 6007-6163, 60001-60029 ; Brilliance 40, M/Ns 9009-9272, 29001-29153, 90028-92034; Brilliance 64, M/Ns 9501-10300, 95003-95697; Brilliance Big Bore, M/Ns 7001-7520; Brilliance iCT, M/Ns 100003-100169 & Brilliance iCT SP, M/Ns 200004-200034. The Brilliance Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 10, 2010