12 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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CAPILLARYS NEONAT HB (PN 2006)
FDA 510(k)
FDA Class 2
·Hematology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450385746·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450311813·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450312728·
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 27, 2024
LIFEMATE HEMOFILTRATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·September 27, 2025
GAS MODULE 3 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BZK·April 30, 2013
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DSI·May 4, 2011
MENTOR
FDA Adverse Event
Injury
·MENTOR·Product code FWM·July 31, 2008
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