BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    D-STAT DRY HEMOSTATIC BANDAGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    n/a

    FDA UDI
    Ortho Development Corporation·00822409074846·12/14 Cemented Broach 12x19

    Encompass Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409011971·STD 12x19mm Stem Cemented

    Mini Sprint ®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70612191·Mini Sprint II Brackets FACE Evolution II Syste...

    BD BBL¿ PSEUDOSEL¿ AGAR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·May 5, 2022

    BD BBL¿ PSEUDOSEL¿ AGAR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·May 5, 2022

    ASCENT KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PLUM A+ DRIVER NEW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 10, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 4, 2014

    EEA XL 25MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·April 5, 2011

    BIOFLO DIALYSIS CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code MSD·June 12, 2020

    BIOFLO DIALYSIS CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code MSD·June 12, 2020

    ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·February 17, 2017

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015