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

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    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVEWRITER ALPHA PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 20, 2024

    2.4MM VA LOCKING SCREW STARDRIVE 22MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·June 25, 2013

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HRS·July 15, 2013

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·May 1, 2013

    ICHEM VELOCITY

    FDA Adverse Event
    Malfunction ·IRIS INTERNATIONAL·Product code KQO·August 28, 2014

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·May 19, 2011

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·December 24, 2015

    EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·February 14, 2025

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    FDA Enforcement
    Class II ·Terminated·Aspen Surgical Products, Inc.·August 28, 2013

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021