BEUDAMED
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    TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517635402·CoRoent Ant TLIF PEEK, 10x10x28mm 12°

    DRI pH-Detect pH 3.6 Control Kit

    FDA UDI
    Microgenics Corporation·00884883005501·

    MAYO-CARROLL DISSECTING SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896047037·MAYO-CARROLL DISSECTING SCISSORS CURVED TUNGSTE...

    FEM. MODULAR HEAD #M D.40MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LPH·October 29, 2022

    SALVIN DENTAL SPECIALTIES FIXATION SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    LATERAL OFFSET PROTRACT PRESS FIT HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTAIN ABILITY STRAIGHT MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·March 11, 2024

    ASR XL TAP SLV ADAP 12/14+2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 8, 2013

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·September 18, 2014

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 16, 2011

    Tracheostomy Tubes, Jackson Improved Short Stainless Steel with Adapter, item number 8100402 size 3,item number 8100040 size 4, item number 8100041 size 5, item number 8100229 size 6, item number 8100322 size 7, item number 8100374 size 8, item number 8100282 size 9, and item number 8100709 size10.

    FDA Recall
    Terminated ·Premier Dental Products Co·Product code JOH·August 5, 2004

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020