12 results · 28ms · 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.

DIALYSIS CONTROL UNIT-CENTRY 2000

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ACUMED

FDA UDI
Acumed LLC·10806378092923·SLIC Screw® Removal Tray Lid

Dermatological Carbon Dioxide Laser Systems

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AURAGEN CORTICAL SURFACE ELECTRODES

FDA 510(k)
FDA Class 2 ·Neurology

RETROFLEX 3 INTRODUCER SHEATH SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 9, 2014

POWERED PATIENT ROTATION BED

FDA Adverse Event
Malfunction ·UNKNOWN·Product code IKZ·October 23, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 6, 2007

DISP.TROCAR THRD.W.DILATING PIN 12/110MM

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code GCJ·July 9, 2019

GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

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

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024