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

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    PINNACLE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950018253·FORCEP TOWEL BACKHAUS 5" 13CM

    Keystone Industries

    FDA UDI
    Keystone Industries·H66870003061·D-2 HVE Tips/White-KI

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034005874·ISOLA SPINE SYSTEM OPEN HOOK,RAISED SUPRALAMINA...

    PROLITE

    FDA UDI
    Atrium Medical Corporation·00650862300055·ProLite Mesh, 3in. x 6in. (7.5cm x 15cm)

    FlowLogic Agile

    FDA UDI
    SONENDO, INC.·00810209420994·FlowLogic Agile Shaping File 17 Variable, 21mm

    IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ENTEC REFLEX WAND 55, MODEL E4055-00

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    POWERLED II

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FTD·December 11, 2025

    PROLITE MESH 3"X3"

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·December 8, 2011

    SMR CEMENTED STEM Ø18 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·November 7, 2023

    HAKIM PROGRAMMABLE VALVE W/SIPHONGUARD

    FDA Adverse Event
    Injury ·Product code JXG·March 12, 2013

    STAIR PRO - MODEL 6252

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPP·February 18, 2011

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·February 14, 2008

    D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FRO·September 15, 2005

    LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.

    FDA Enforcement
    Class II ·Terminated·LumiraDx·February 24, 2021

    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

    BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView XCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017

    BrightView XCT , Model Number 882482

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019