12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEQUALIS RESURFACING HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
A1CNOW FOR HOME USE
FDA 510(k)
FDA Class 2
·Hematology
HARDYDISK CEFOTETAN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
GORE® PROPATEN® VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·March 16, 2021
ENDOGASTRIC SOLUTIONS ESOPHYX2
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS·Product code ODE·March 25, 2013
BARD URETERAL CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC.·Product code EYB·June 12, 2008
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 11, 2011
CONSULT HCG URINE CASSETTE 5001 25T
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019
GORE® PROPATEN® VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·May 19, 2021
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