11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOPRO 225 DUAL HALOGEN LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019910026·TPLIF Cage Peek 12mm x 29mm
ShurFit 2C Lumbar Interbody
FDA UDI
PRECISION SPINE, INC.·00840019929875·12mm x 29mm 2C TPLIF Cage PEEK
POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 28, 2024
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 23, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·April 29, 2011
KAPPA 700 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·July 10, 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