9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967162461·NARROW BLADE OFFSET THORACIC SUPRALAMINAR HOOK,...
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
FDA 510(k)
FDA Class 2
·Radiology
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 28, 2025
TI CLICK X LOCKING CAP FOR TI3-D HEAD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MNI·March 27, 2013
CCU BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·March 11, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·April 5, 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