10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MICRO TARGETING DRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·April 16, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·June 13, 2008
SCREW, CANN. DELTA TAPERED BIO-INT. 10MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·April 19, 2011
CHLORAPREP ONE STE HI LITE ORANGE
FDA Adverse Event
Malfunction
·CAREFUSION 213, LLC 0113·Product code KXG·June 28, 2021
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