9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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