BEUDAMED
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    MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ROLLO 210X25X16E/OEM BTL08LC

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763005698·

    Humeris Shoulder

    FDA UDI
    FX SOLUTIONS·03701037304549·TRIAL HUMERIS STEM T18

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690115427·Retaining Bolt PS or PS-C Insert, Modular Tibia...

    MedGyn Laminaria

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803021018·Dilator of Uterine Cervix

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00350770949895·MIC* Gastro-Enteric Feeding Tubes

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651949896·HALYARD* MIC* Gastro-Enteric Feeding Tubes-18-6...

    TAUT BALLOON CATHETER, MODEL 50640

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910

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

    740 SELECT

    FDA UDI
    ZOE MEDICAL INCORPORATED·00851920007132·The 740 SELECT Monitor is intended for monitori...

    POLARIS

    FDA UDI
    HNM TOTAL RECON LLC·00841742113302·POLARIS ø4.0mm/ø3.0mm High Compression Screw, C...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 24, 2025

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 28, 2017

    Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·March 25, 2020

    PENUMBRA SMART COIL DETACHMENT HANDLE

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·August 19, 2021

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 26, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    SIROLIMUS COATED SMART STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·March 26, 2008

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014