10 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517320841·CoRoent® LO Ti, 13x10x40mm 5°
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014600222·Disposable Richards Slotted Headrest, Extended
STACKABLE CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 2, 2026
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 26, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR GALWAY·Product code NIM·July 24, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 21, 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