12 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERAROOT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450053188·
BURETTE-IN LINE (150 ML)
FDA 510(k)
FDA Class 2
·General Hospital
PREMIER III PHASED ARRAY CTL SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
UNKNOWN
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code NA·April 14, 2011
LCP® DHHS(TM) INSERTER GUIDE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code FZX·May 6, 2013
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·December 10, 2024
EDWARDS TRANSCATHETER INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 11, 2019
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·January 5, 2023
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