BEUDAMED
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    BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Safco NiTi RL Rotary Files

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310208343·Safco NiTi RL rotary files, #40, (0.4 taper / 2...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743731·ACHIMED ACHILLES SUPP SAND IV

    POLARIS

    FDA UDI
    HNM TOTAL RECON LLC·00841742113388·POLARIS ø4.0mm/ø3.0mm High Compression Screw, C...

    SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO

    FDA 510(k)
    FDA Class 1 ·Dental

    CRW Non-XY frame Mechanical Set KIT

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·27290114064082·

    CRW Non-XY frame Mechanical Set KIT

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·27290114061104·

    CRW Non-XY frame Mechanical Set KIT

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·27290016450952·

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·May 30, 2007

    AFFINITY CP PUMP

    FDA Adverse Event
    MEDTRONIC·Product code KFM·March 19, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 16, 2011

    HEARTMATE 3 LVAS MINI APICAL CUFF KIT

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·January 27, 2021

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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