BEUDAMED
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    MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780750·LEVAMED ACTIVE ANKLE SUP SLVR L III

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517282781·CoRoent® Large MP, 12x9x23 4°

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112230·Tap, 5.50mm, Cannulated, Fixed Sleeve

    QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ACULUX, MODEL AX3001, AX3002

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

    9611993-2023-041223

    FDA Adverse Event
    Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·February 14, 2023

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 8, 2013

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 30, 2011

    PRECISION XTRA / OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·May 8, 2008

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 22, 2024

    THREE PEG PATELLA 35MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 24, 2025

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·October 15, 2014

    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 Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018