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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ONE-STEP PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code HSD·June 18, 2009
SI ASCOPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013
OPTA PRO PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS EUROPA, N.V.·Product code LIT·May 9, 2008
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·April 6, 2011
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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