BEUDAMED
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    LINEAGE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099693·MAN MLR BDS ASST 100 SE ASIA

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002149·artVeneer life lower posteriors, XS, D3

    MAMMARY PROSTHESIS

    FDA Adverse Event
    DOW CORNING CORP.·Product code FTR·May 23, 1994

    NOVABONE-BIOGLASS BONE GRAFT PARTICULATE

    FDA 510(k)
    FDA Class 2 ·Dental

    AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HF SENSOR DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code MOM·May 31, 2023

    HF SENSOR DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code MOM·November 19, 2019

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·February 4, 2011

    N595 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·FORMERLY NELLCOR PURITAN BENNETT·Product code DQA·February 25, 2008

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·June 10, 2025

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024