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

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    GSB GLOBAL SPINAL BALANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    A.S.A.P.® All Surface Access Polishers Final High Shine 3-Pack Refill (Small)

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012959·Dental polishing point

    A.S.A.P.® All Surface Access Polishers Final High Shine 3-Pack Refill (Small)

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883004958·Dental polishing point

    OSE

    FDA UDI
    ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00869843000260·Zinc Phosphate Cement Powder

    MEGA PLUS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665580146·Rod(CoCr), Ø6.0 x 140mm

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00190376215655·Fixed 2.3mm Drill Bit, 14mm

    ihcDirect® Cytokeratin 5 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596139·Clone R226

    RAVINE Lateral Access System

    FDA UDI
    VB Spine LLC·10888857560604·Lateral Access Blade Size 24x200 mm

    N LATEX IGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    TENS STIMULATOR, MODELS 2800 AND 3000

    FDA 510(k)
    FDA Class 2 ·Neurology

    OPTUNE GIO

    FDA Adverse Event
    Injury ·NOVOCURE GMBH·Product code NZK·August 14, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 13, 2014

    LEAVE ACTIVE PFC CVD 8MM SZ4

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 29, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·October 1, 2014

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    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

    Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016