9 results · 33ms · Sources: EU EUDAMED, US FDA

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EMIT-STM ETHYL ALCOHOL URINE CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

SURE-SNAP

FDA UDI
Gc Orthodontics America Inc.·E53580261800001·SURE-SNAP 1. MOLAR UPR LFT SZ 18

ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED

FDA 510(k)
FDA Class 2 ·Anesthesiology

ECHELON LINEAR CUTTER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2014

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 19, 2012

SPRINTER OTW

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code LOX·May 28, 2015

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