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Elekta, Inc.

113 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic d recall (Z-1411-2010)Elekta, Inc.2010-04-22
Leksell SurgiPlan recall (Z-1428-2010)Elekta, Inc.2010-04-22
Leksell Gamma Knife C recall (Z-1429-2010)Elekta, Inc.2010-04-22
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, recall (Z-1405-2010)Elekta, Inc.2010-04-16
PrecisePLAN 2.10 Treatment Planning System recall (Z-1406-2010)Elekta, Inc.2010-04-16
Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the recall (Z-1236-2010)Elekta, Inc.2010-04-13
Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 71500 recall (Z-1230-2010)Elekta, Inc.2010-04-05
Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcros recall (Z-1231-2010)Elekta, Inc.2010-04-05
Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy syst recall (Z-1232-2010)Elekta, Inc.2010-04-05
Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy t recall (Z-1159-2010)Elekta, Inc.2010-03-18
Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotact recall (Z-1158-2010)Elekta, Inc.2010-03-17
PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radi recall (Z-1109-2010)Elekta, Inc.2010-03-16
Desktop Pro R6.0 & R6.1, Linear Medical Accelerator. recall (Z-0421-2007)Elekta, Inc.2007-02-07
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