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

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ZEPPELIN FORCEPS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MULTI-STIM, MODEL MS-100

FDA 510(k)
FDA Class 2 ·Neurology

BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019

FDA 510(k)
FDA Class 2 ·Cardiovascular

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 7, 2014

EX-PRESS MINI GLAUCOMA SHUNT

FDA Adverse Event
Injury ·OPTONOL, LTD·Product code KYF·November 12, 2010

SIG TKA GDE/MDL SET 03-05

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·January 8, 2013

ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE

FDA Adverse Event
Injury ·COOK INC·Product code DQX·January 26, 2018

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

TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021