7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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Gyn Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Gyn Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
FDA Recall
Completed
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JWH·April 26, 2023
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYN·July 22, 2021
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
FDA Recall
Completed
·Philips Ultrasound, LLC·Product code IYN·July 14, 2022