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

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    EVOLVE Nitric Oxide Delivery System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UltraCare Blood Lancets

    FDA UDI
    ARISE MEDICAL LLC·00372217002017·UltraCare Blood Lancets - 100 Count

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982165053·L-BUTTRESS PLTE/10 HOLES/181MM ANGLED LEFT FOR ...

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690102007·All Poly 3 Peg Patella 41 mm x 10 mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127741·Patella Trial 41mm x 10mm

    Holder, Needle, TC, Mini-Ryder 12cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034066393·Holder, Needle, TC, Mini-Ryder 12cm ...

    GREENLIGHT 300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reconnaissance PV .018 OTW Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 2, 2023

    ITRACK ADVANCE

    FDA Adverse Event
    Injury ·NOVA EYE, INC.·Product code MPA·August 6, 2024

    ITRACK ADVANCE

    FDA Adverse Event
    Injury ·NOVA EYE, INC.·Product code MPA·August 6, 2024

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    PASSIVE PLUS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    LCS TEX PCR TIB PLAT STD+

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code NJL·July 22, 2013

    TPRLC 133 FP TYPE1 PPS HO 7.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·March 12, 2025

    Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Zimmer Surgical Inc·February 4, 2026

    PKG, COBRA FORCEPS, P/N 0250080317. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014