17 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.

DURACON PS LIPPED TIBIAL INSERT

FDA 510(k)
FDA Class 2 ·Orthopedic

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040018903·Zirlux 16+ D98,5*30 (step) C1

UNBRANDED

FDA UDI
FGX INTERNATIONAL INC.·00193033359501·

UniTip Catheter

FDA UDI
Unisensor AG·07640172973875·

UniTip Catheter

FDA UDI
Unisensor AG·07640172973790·

K042172

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022

LEAD BLOCKS

FDA 510(k)
FDA Class 2 ·Radiology

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)

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

INSET II

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 30, 2025

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·February 1, 2011

CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·June 26, 2019

XLUNG KIT 230

FDA Adverse Event
Malfunction ·XENIOS AG·Product code QJZ·November 9, 2023

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024