BEUDAMED
    19 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 28, 2016

    3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 28, 2016

    Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems·February 28, 2018

    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·September 3, 2025

    Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 24, 2024

    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems·February 28, 2018

    Comprehensive Mini Stem, Item No. 113631:

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 19, 2018

    Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 19, 2018

    SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 8, 2015

    SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 8, 2015

    Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·November 20, 2013

    BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·October 29, 2025

    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Enforcement
    Class II ·Terminated·SANTA JOY ORNAMENT & GIFTWARE CO·June 13, 2018

    Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700

    FDA Enforcement
    Class II ·Terminated·Bayer Medical Care, Inc.·January 23, 2019