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

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    VERAVIEW IC 5, MODEL XDP1

    FDA 510(k)
    FDA Class 2 ·Dental

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690185444·Revision Knee Spiral Reamer- Hudson Short Flute...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809841879·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE SMALL AN...

    NA

    FDA UDI
    STERILMED, INC.·10888551020145·SAW BLADE MICRO RECIPROCATING

    CONMED

    FDA UDI
    Conmed Corporation·10845854009581·MICRO RECIPROCATOR BLADE, 25.5 X 0. 4 MM

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981174149·L Con, Side-Loading, L, 16mm, 220mm

    EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00813939023763·EndoVive Gastrostomy Tube, Right Angle, with EN...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 17, 2026

    PERSONAL ECG TRANSMITTER, MODEL CG-6550

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    9611993-2025-053220

    FDA Adverse Event
    Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·March 1, 2025

    ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 11, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 13, 2011

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·May 28, 2008

    REF H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).

    FDA Recall
    Terminated ·Theken Spine Llc·Product code NOX·August 26, 2010

    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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016