BEUDAMED
    34 results · 43ms · Sources: EU EUDAMED, US FDA

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    SURGICAL THEATER, INC.

    FDA registration
    SURGICAL THEATER, INC.·2 products·🇺🇸 United States

    Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system

    FDA Recall
    Open, Classified ·Surgical Theater Inc·Product code LLZ·September 16, 2025

    SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system

    FDA Recall
    Open, Classified ·Surgical Theater Inc·Product code LLZ·September 16, 2025

    Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

    FDA Recall
    Open, Classified ·Surgical Theater Inc·Product code LLZ·September 16, 2025

    Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system

    FDA Recall
    Open, Classified ·Surgical Theater Inc·Product code LLZ·September 16, 2025

    SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

    FDA Recall
    Open, Classified ·Surgical Theater Inc·Product code LLZ·September 16, 2025

    SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality

    FDA Recall
    Open, Classified ·Surgical Theater Inc·Product code SFB·September 16, 2025

    Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

    FDA Recall
    Open, Classified ·Surgical Theater Inc·Product code LLZ·September 16, 2025

    Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system

    FDA Enforcement
    Class II ·Ongoing·Surgical Theater Inc·November 5, 2025

    Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system

    FDA Enforcement
    Class II ·Ongoing·Surgical Theater Inc·November 5, 2025

    SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

    FDA Enforcement
    Class II ·Ongoing·Surgical Theater Inc·November 5, 2025

    Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

    FDA Enforcement
    Class II ·Ongoing·Surgical Theater Inc·November 5, 2025

    SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system

    FDA Enforcement
    Class II ·Ongoing·Surgical Theater Inc·November 5, 2025

    Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

    FDA Enforcement
    Class II ·Ongoing·Surgical Theater Inc·November 5, 2025

    SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality

    FDA Enforcement
    Class II ·Ongoing·Surgical Theater Inc·November 5, 2025

    BAIR HUGGER THERMAL REGULATOR

    FDA Adverse Event
    Injury ·3M·Product code DWJ·October 28, 2016

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·September 6, 2019

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·September 4, 2019

    DA VINCI XI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·March 12, 2026

    DAVINCI XI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·March 30, 2026