10 results · 19ms · Sources: EU EUDAMED, US FDA

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ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01

FDA 510(k)
FDA Class 2 ·Immunology

NA

FDA UDI
FORTEC FIBERS, INC.·00816901020036·

EECP THERAPY SYSTEM, MODEL TS3

FDA Adverse Event
Injury ·VASOMEDICAL, INC.·Product code DRN·December 30, 2002

PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION OF NC-STAT

FDA 510(k)
FDA Class 2 ·Neurology

LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·April 26, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 4, 2011

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