10 results · 26ms · Sources: EU EUDAMED, US FDA

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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