12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
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