10 results
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19ms
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Sources: EU EUDAMED, US FDA
GASTROSTOMY FEEDING CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083016401·STR, 4 electrode, MPD-S-L, 2-5-2mm electrode sp...
B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP·Product code MZI·January 15, 2014
THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
FDA 510(k)
FDA Class 2
·General Hospital
MEDTRADE PRODUCTS CELOX TRAUMA GAUZE
FDA 510(k)
FDA Unclassified
·Unknown
HERCULES III 360
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code MWS·May 8, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·January 8, 2013
COMBINATION SET 102", ANTI-SIPHON
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·November 17, 2010
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
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