12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENVOY GUIDING CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450426296·
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
ACL TOP
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005
ACL TOP
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005
VET DCP 3.5 8HO L97 SST
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·May 4, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 16, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 3, 2011
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