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