BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    AUTOGEL PAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 18mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009293·

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037313466·STABILITY TRIAL CUP Ø36 + 18 STANDARD TRIAL HUM...

    Raw Surgical Corporation

    FDA UDI
    RAW SURGICAL CORPORATION·G508RSC10310180·GERALD FORCEPS, Fine, 1 x 2 teeth, Overall leng...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...

    InTess L

    FDA UDI
    Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square

    TAUT BALLOON CATHETER, MODEL 50640

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

    REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SEE H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 4, 2011

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN·Product code FTR·November 15, 2012

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008

    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

    FDA Enforcement
    Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024