8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OMNI 2 OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNVITRO FLUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 13, 2011
MICROSTAAR INJECTOR CARTRIDGE
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code MSS·July 24, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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