10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROCEDURE MASKS: PM4-301 AND PM4-304
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·January 10, 2020
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 29, 2013
ADVANTAGE SERIES 29
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 13, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 18, 2008
GORE® TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 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