BEUDAMED
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    VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    2040 Ceramic Brackets

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746005756·COSMETIC 20/40 LL 1ST BIC 018 T-12 A+2 R=0

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113607·PS-C Insert, Size 3 x 16mm

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981157241·Cambria Trial without Depth Stop

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Other ·MERZ AESTHETICS, INC.·Product code LMH·January 12, 2012

    CAP TIP SYR LL/LS STER LF PP NAT 50/TRAY

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code KYW·September 8, 2021

    PERMACEM / PERMACEM DUAL

    FDA 510(k)
    FDA Class 2 ·Dental

    PHOENIX DIGITAL EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEVICE 8252410 NIM-NEURO 2.0 INTERFACE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code IKN·February 21, 2014

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Other ·MERZ AESTHETICS, INC.·Product code LMH·January 26, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 17, 2011

    DTC MARGRON HIP REPLACEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·PORTLAND ORTHOPAEDICS LTD.·Product code KWY·April 1, 2008

    PUMP 1886 780G OUS BLE PUMP MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 4, 2023

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023