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

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    CARESCAPE MODEL V100 VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664010720·BELLA STRONG 30-40 MM HG ARMSLEEVE KNIT WELT SI...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502344·Gutta Percha Points is used to root canal filin...

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971369·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973233·

    THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY

    FDA 510(k)
    FDA Class 2 ·Dental

    CEROS TCP GRANULES

    FDA 510(k)
    FDA Class 2 ·Dental

    CARDIOHELP SYSTEM

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 23, 2015

    INFUSE BONE GRAFT 12 MG

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code NEK·May 1, 2014

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016

    OUTLOOK ES

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·April 30, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 19, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2011

    SCREWDRIVER BIT T15, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

    SCREWDRIVER BIT T15, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    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

    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