12 results · 22ms · Sources: EU EUDAMED, US FDA

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SIASCOPE V

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

MONOJECT SAFETY NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

HEART 2006

FDA 510(k)
FDA Class 2 ·Cardiovascular

MAGELLAN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code FMI·September 6, 2023

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 17, 2013

TRIATHLON PS FEM COMPONENT, CEMENTED

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 13, 2011

QUICKIE

FDA Adverse Event
Injury ·SUNRISE MEDICAL·Product code ITI·June 17, 2008

O-ARM O2 IMAGING SYSTEM

FDA Adverse Event
Malfunction ·SANMINA -SCI SYSTEMS·Product code OWB·November 4, 2021

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015