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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Persona Revision Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010513649·T-MAX BEACH CHAIR SHOULDER POSITIONER

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180108479·5 MM DIA., 45 CM INSULATED KNIFE TIP ELECTRODE,...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180124790·5MM DIA., 36CM, INSULATED KNIFE TIP ELECTRODE, ...

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5

    BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 12, 2019

    EBI DYNAFIX VS OSTEOTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T-MAX EXPOSURE SHOULDER POSITIONER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code FWZ·February 26, 2016

    T-MAX II SHOULDER EXPOSURE POSITIONER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code FWZ·December 12, 2015

    TOTAL ASR FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·October 22, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    T-MAX EXPOSURE SHOULDER POSITIONER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code FWZ·November 16, 2016

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024

    MECTALIF TRANSFORAMINAL CAGES TIPEEK

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015