5 results
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65ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Systems, Inc. 1 Shelia Drive, Tinton Falls, NJ; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO, Single Use.
FDA Recall
Terminated
·Enpath Medical, Inc·Product code DTB·July 18, 2006
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.
FDA Recall
Open, Classified
·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.
FDA Enforcement
Class II
·Ongoing·Angel Medical Systems, Inc.·February 19, 2025
SONENDO GENTLEWAVE SYSTEM
FDA Adverse Event
Injury
·SONENDO, INC.·Product code ELC·May 2, 2025
ARIA, RT Chart Application v 8.0 through 8.9 Varian Medical Systems, Palo Alto, CA. Aria Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·March 9, 2011