BEUDAMED
    100 results · 35ms · Sources: EU EUDAMED, US FDA

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    SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ArgenZ HT+ 98x14 D3

    FDA UDI
    ARGEN CORPORATION, THE·D818122024·Dental porcelain/ceramic restoration kit

    16PW - Bleed Control - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620244·16PW - Bleed Control - Poly White

    BioHorizons

    FDA UDI
    BIOHORIZONS IMPLANT SYSTEMS, INC·00847236000981·2.0 x 24mm CGS Pilot Drill

    MiniSPC Button

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071152246·12F x 2.0cm MiniSPC Low Profile Suprapubic Cath...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 19, 2024

    NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RPM RESPIRATORY GATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·September 23, 2024

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD.·Product code HQL·May 16, 2013

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·June 9, 2011

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 14, 2008

    BD SAFETYGLIDE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·January 14, 2025

    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.

    FDA Enforcement
    Class II ·Ongoing·Quidel Corporation·February 21, 2024

    regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 30, 2022

    regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 30, 2022

    3,65 m Extension Set with Luer-lock Connector

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·June 8, 2022

    Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs

    FDA Enforcement
    Class II ·Terminated·Pyng Medical Corporation·November 11, 2015

    Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024