BEUDAMED
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    Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NA

    FDA UDI
    Synthes GmbH·10886982157706·3.5MM MEDIAL DISTAL TIBIA PLATE 8 HOLES/121MM-R...

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540355875·Locking Screws, Cross-Pin

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·37613154156468·LOCKING SCREWS, CROSS-PIN, SELF-TAPP.

    TRINIAS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BriefCase

    FDA 510(k)
    FDA Class 2 ·Radiology

    GMK SPHERE CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

    SARA 3000

    FDA Adverse Event
    Malfunction ·MEDIBO MEDICAL PRODUCTS NV·Product code FSA·July 13, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 12, 2013

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026