BEUDAMED
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    QUICKVUE ONE-STEP HCG-COMBO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743700·ACHIMED ACHILLES SUPP SAND I

    Safco NiTi RL Rotary Files

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310208013·Safco NiTi RL rotary files, #15, (0.4 taper / 2...

    In-line Ratcheting Handle Cann Hud-Mod

    FDA UDI
    Osteocentric Technologies, Inc.·00810097801172·In-line Ratcheting Handle Cann Hud-Mod

    ADAPTOR,8,P2020,S2020,1/4"N

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828119290·ADAPTOR,8,P2020,S2020,1/4"N

    Phonak

    FDA UDI
    Phonak AG·07613275257876·Phonak Audéo V50-312T (beige)

    Phonak

    FDA UDI
    Sonova AG·07613275553022·Phonak Virto B50-10 NW O

    MPS M ELECTRODE

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

    PC COATED FLUOROPLASTIC VENT TUBES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007

    10 MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Injury ·ETHICON·Product code FZP·March 20, 2013

    SIGNATURE INSTRUMENTATION

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code JWH·March 8, 2011

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018