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

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    Sterile Nitrile Surgical Gloves, Powder-free

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003586·MCK FEMORAL TRIAL (SIZE 5 RM/LL)

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707018773·CALIBRA 1ST MOLAR BANDS n.LL 15

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E8961705150·Papilla elevator SWORD-DESIGN, 17,5cm Ø1,5mm...

    UCP DRUG SCREENING TEST CUPS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    A-VIEW BASIC AND PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·May 9, 2017

    ECHELON*FLEX45 COMPACT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 21, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 14, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 29, 2014

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·May 9, 2017

    LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·January 1, 2025

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022