9 results · 21ms · Sources: EU EUDAMED, US FDA

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REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SYNCHRON VANCOMYCIN REAGENT

FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011

SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MITEK CUFFTACK

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDFUSION 3500 SYRINGE INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL MD·Product code FRN·February 18, 2013

MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code EIA·September 5, 2014

CONTOUR TEST STRIPS

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 11, 2011

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015