16 results
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26ms
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Sources: EU EUDAMED, US FDA
IVENT 201 PORTABLE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50
MHS 5000
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
FDA 510(k)
FDA Class 2
·Immunology
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·March 26, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 10, 2011
ADVANCE II COCR TIBIAL BASE
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRY·March 28, 2008
SMARTNAIL
FDA Adverse Event
Injury
·CONMED CORPORATION·Product code MAI·July 29, 2019
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 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
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014