10 results · 27ms · 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.

INOMAX DS

FDA 510(k)
FDA Class 2 ·Anesthesiology

CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

NITRILE EXAMINATION GLOVES (POWERED)

FDA 510(k)
FDA Class 1 ·General Hospital

2008T HEMODIALYSIS SYS., WITH CDX

FDA Adverse Event
Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 26, 2018

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·May 6, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

ZUK ARTICULAR SURFACE PROVISIONAL

FDA Adverse Event
Malfunction ·ZIMMER INC·Product code LXH·April 19, 2011

BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code JKA·July 3, 2019

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 REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024