9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE PARALLEL Y CONNECTORS
FDA 510(k)
FDA Class 1
·Cardiovascular
PROTEIN C REAGENT
FDA 510(k)
FDA Class 2
·Hematology
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·September 20, 2012
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·May 9, 2014
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 17, 2010
BD PLATE CAMPYLOBACTER SB 100MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022
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