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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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