7 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Impella RP with SmartAssist; Product Number: 0046-0035;
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·January 22, 2025
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number U225 VISIONIST CRT-P EL
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025