13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SterilContainer S System
FDA 510(k)
FDA Class 2
·General Hospital
SURELIFT PROLAPSE SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
QUANTUM BARIATRIC 451
FDA 510(k)
FDA Class 2
·Physical Medicine
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·July 15, 2011
GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·June 11, 2013
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·October 10, 2014
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 8, 2013
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·January 5, 2022
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·December 21, 2022
ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Medical charged-particle radiation therapy system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·April 9, 2009
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·December 9, 2021
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code IYE·November 9, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022