10 results
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21ms
·
Sources: EU EUDAMED, US FDA
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
FDA 510(k)
FDA Class 2
·General Hospital
K-ASSAY HS-CRP CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
FDA 510(k)
FDA Class 2
·Physical Medicine
BD BBL¿ MUELLER HINTON II AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JTZ·April 25, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 4, 2025
CAPSURE
FDA Adverse Event
Injury
·MPRI·Product code NVN·April 10, 2013
ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·April 12, 2011
SHILEY PED
FDA Adverse Event
Injury
·COVIDIEN/ FORMERLY TYCO HEADQUARTERS·Product code BTO·May 21, 2008
BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 10, 2023
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