BEUDAMED
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    BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138127463·BICRO KNEE IMMOBILIZER W/PATELLA STRAP 12.5IN UN

    TIII Traction Splint

    FDA UDI
    FARETEC, INC.·B54111235120·TIII Leg traction splint with molded ratchet, P...

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540492029·LOCKING SCREW, CROSS-PIN

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376536132·SPS VA Self-Drill Screw, 3.5 x 12 mm

    MiniSPC Button

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071152338·12F x 3.5cm MiniSPC Low Profile Suprapubic Cath...

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052331·3.5mm x 12mm Poly Screw Assm. The Atoll OCT Spi...

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210166445·Polyaxial Screw, 3.5mm x 12mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376657080·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 12mm

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981040727·Screw - Self-Drilling - 3.5x12mm

    AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PICUS ULTRASOUND IMAGING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPT SLEEVE 12X100 STABILITY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019

    TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·June 8, 2011

    WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016