BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    SERRALSILK

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

    Healqu

    FDA UDI
    Healqu LLC·00819143020888·Healqu Transparent Dressing (23/8 x 23/4)

    ROLLO 209X20X205EK600(ETOILE

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763005520·

    M6-C

    FDA UDI
    Spinal Kinetics, Inc.·00812388031237·Inserter Head, M, G7

    Phonak

    FDA UDI
    Sonova AG·07613275553039·Phonak Virto B30-10 NW O

    Phonak

    FDA UDI
    Phonak AG·07613275428689·Phonak Audéo V90-R (beige)

    NA

    FDA UDI
    STRYKER CORPORATION·07613153001126·4.0mm Oval Solid Carbide Bur Long

    KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION

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

    KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER

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

    Optimotion Blue CR HCCR Total Knee System

    FDA UDI
    OPTIMOTION IMPLANTS LLC·B6961014P0209010·CR Tibial Insert, UHMWPE + Vitamin E, Size 2, ...

    PP DP PATIENT TUBING SINGLE

    FDA Adverse Event
    Injury ·BIOMET SPORTS MEDICINE·Product code HRX·October 22, 2012

    PP DP DAY CASSETTE SINGLE

    FDA Adverse Event
    Injury ·BIOMET SPORTS MEDICINE·Product code HRX·October 22, 2012

    FREESTYLE FLASH

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

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 18, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 16, 2011

    THE ELECTRODE STORE

    FDA Adverse Event
    Malfunction ·THE ELECTRODE STORE·Product code GXZ·July 17, 2021

    HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·March 27, 2024

    Spectral CT. Computed tomography X-ray system.

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

    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