15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE PRESSURE LINE ADAPTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
Precept
FDA UDI
Nuvasive, Inc.·00887517285614·PRECEPT Reduction Counter Torque
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828012600·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
BD PLASTIPAK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·May 1, 2018
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ALLROUND 55 LF
FDA 510(k)
FDA Class 2
·Dental
PHYSICA
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code JWH·March 16, 2026
ACCESS® ACCUTNI
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·May 8, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 17, 2012
TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 11, 2010
VIDAS® HS TROPONIN I
FDA Adverse Event
Injury
·BIOMERIEUX SA·Product code MMI·May 10, 2017
VIDAS® HS TROPONIN I
FDA Adverse Event
Injury
·BIOMERIEUX SA·Product code MMI·May 10, 2017
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024