9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
PSA4000 EEG MONITOR WITH FRONTAL PSI
FDA 510(k)
FDA Class 2
·Neurology
EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING
FDA 510(k)
FDA Class 1
·General Hospital
DULERA INHALER (DEVICE)
FDA Adverse Event
Malfunction
·MERCK SHARP & DOHME CORP. WILSON·Product code KCO·December 26, 2022
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·March 26, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 16, 2011
ASCENSIA BREEZE2
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·March 27, 2008
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
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024