20 results · 29ms · Sources: EU EUDAMED, US FDA

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MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ODYSSEY®

FDA UDI
Microport Orthopedics Inc.·M684K00143381·

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001338·artVeneer life upper anteriors, BOM, C2

OptiMesh Multiplanar Expandable Interbody Fusion System

FDA UDI
SPINEOLOGY INC.·M7401001338·TLIF Portal Anchor, Angled 4mm

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·March 21, 2025

N/A

FDA UDI
Doppkon GmbH & Co. KG·04262494463112·Tendon Stripper Closed OD 9.5mm, WL 330mm

UniTip Catheter

FDA UDI
Unisensor AG·07640172971673·

VITAPORT 3

FDA 510(k)
FDA Class 2 ·Neurology

AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354

FDA 510(k)
FDA Class 2 ·Cardiovascular

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·June 15, 2018

TEMA ELBOW

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code JDB·October 2, 2025

ENDO GIA UNIVERSAL 12MM SINGLE USE INST

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·March 6, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·February 25, 2011

INRATIO

FDA Adverse Event
Malfunction ·HEMOSENSE SJ·Product code JPA·February 19, 2008

Xhibit Telemetry Receiver, Model: 96280

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Enforcement
Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

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

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024