10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BOUNDARY SINGLE-USE DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INFRARED EAR THERMOMETER, MODEL ET-101A
FDA 510(k)
FDA Class 2
·General Hospital
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 23, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 17, 2010
BD SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 29, 2019
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025