BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    GYRUS PLASMA SKIN RESURFACING SYSTEM

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496023111·MISS RELAX 100 SHEER, SIZE S, AVORIO, GRADUATED...

    True Position®

    FDA UDI
    ATLAS SPINE, INC.·M68112080231110·31mm x 11mm Non-Lordotic Spacer

    NA

    FDA UDI
    STRYKER CORPORATION·04546540945006·Precision Offset (9.0 x 0.254 x 25.0mm)

    IMPLANT: HA, 10MM,INTEGRAL, 4.0

    FDA Adverse Event
    Injury ·CALCITEK·Product code DZE·October 11, 1996

    EXHALE PROBE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES

    FDA 510(k)
    FDA Class 2 ·Neurology

    PLM NICDRP NITRO OL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 26, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 24, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·April 3, 2008

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code MFA·February 8, 2023

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    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