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

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    INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP

    FDA 510(k)
    FDA Class 2 ·Radiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450426364·

    SE-300 VACUUM THERAPY SYSTEM

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

    BIOKNOTLESS ANCHOR

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

    IMPL TAPERED SP 3.7MM 12M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

    IMPL TAPERED SP 3.7MM 12M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 12, 2024

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

    CROSSFLOW CONSOLE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code HRX·May 3, 2013

    6FX60CM DUAL PRO LINE CT

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code LJS·August 19, 2014

    THORATEC VENTRICULAR ASSIST (VAD) SYSTEM

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·May 10, 2011

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 27, 2023

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 3, 2023

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 31, 2019

    MANTIS REDUX BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·November 27, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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