17 results · 25ms · Sources: EU EUDAMED, US FDA

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SUMMIT STAIRWAY LIFT

FDA 510(k)
FDA Class 2 ·Physical Medicine

COR-KNOT MICRO

FDA UDI
LSI Solutions, Inc.·00850012846659·COR-KNOT MICRO® XL

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032880·Baltic Denture System BDLoad Sw7 PLSEbm6DFs B2 ...

300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC

FDA 510(k)
FDA Class 2 ·Radiology

STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

AVALUS AORTIC TISSUE VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020

LIBERTY CYCLER SET, SINGLE CONN/EXT DL

FDA Adverse Event
Malfunction ·REYNOSA MANUFACTURING·Product code FKX·March 29, 2013

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·March 29, 2011

GENIE

FDA Adverse Event
Injury ·SULTAN HEALTHCARE·Product code ELW·April 23, 2008

ARCOS CONE PROXIMAL BODY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·December 27, 2017

M2A-MAGNUM PF CUP 54ODX48ID

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 27, 2017

EDWARDS INFLATION DEVICE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025

EDWARDS INFLATION DEVICE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025

EDWARDS INFLATION DEVICE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024