12 results · 20ms · Sources: EU EUDAMED, 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