16 results · 26ms · Sources: EU EUDAMED, US FDA

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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