17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CELSITE/ CELSITE CONCEPT, ACCESS PORTS
FDA 510(k)
FDA Class 2
·General Hospital
TASMIN R 6°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014608·The basic shape of the TASMIN R devices is a ho...
MI Product Line
FDA UDI
Medical Illumination International Inc.·00816835020201·MI-750 Minor Surgical Light, Single Ceiling
MI Product Line
FDA UDI
Medical Illumination International Inc.·00816835020768·MI-750 Minor Surgical Light, Single Ceiling
VISION EX5
FDA UDI
Avante·00815871022262·DRE Vision EX5, SINGLE CEILING
VISION EX5
FDA UDI
Avante·00815871022309·DRE Vision EX5, SINGLE CEILING
IL TEST PROS
FDA 510(k)
FDA Class 2
·Hematology
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
FDA 510(k)
FDA Class 2
·General Hospital
EXCHANGE TRANSFUSION TRAY - NEONATAL
FDA Adverse Event
Malfunction
·MARIAN MEDICAL, INC·Product code FPA·October 11, 2024
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2019
XLD 110V L.A. REF
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 10, 2013
MEDTRONIC SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code MHY·April 7, 2011
UNKNOWN PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 17, 2008
MI-750
FDA Adverse Event
Malfunction
·MEDICAL ILLUMINATION INTRNATION INC.·Product code FSY·January 17, 2023
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
FDA Recall
Terminated
·Quidel Corporation·Product code PSZ·September 25, 2020
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015