BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    REDON SET

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

    L12-3E Ultrasonic Transducer(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904087894·

    Sonova Brand

    FDA UDI
    Sonova AG·07613389477092·myPhonak Junior app

    GE LOGIQ 700

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·January 27, 2026

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·November 6, 2025

    DRIVER SHAFT, T-15, MEDIUM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code LXH·August 17, 2020

    VERCISE? CARTESIA? X

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code PJS·December 29, 2025

    KEEPSAFE DELUXE NO POWER SWITCH

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·March 8, 2013

    PROGENIX DBM PUTTY

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQV·February 25, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·February 15, 2008

    Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014

    PERI GYN PACK 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1 ) TABLE COVER REINFORCED 50" X 90" UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024