15 results · 21ms · Sources: EU EUDAMED, US FDA

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INTRABEAM SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MODEL 4300 PSARRAY EEG ELECTRODE SET

FDA 510(k)
FDA Class 2 ·Neurology

9617032-2017-00160

FDA Adverse Event
Malfunction ·December 1, 2017

RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

FDA Adverse Event
Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020

SPRINT FIDELIS

FDA Adverse Event
Injury ·MPRI·Product code LWS·April 10, 2013

PROSTAR XL SUTURE-MEDIATED CLOSURE

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·May 22, 2008

CONTINUUM LONGEVITY CROSSLINKED POLY LINER

FDA Adverse Event
Injury ·ZIMMER INC·Product code JDI·April 5, 2011

ARROW MULTI-LUMEN/PSI KIT: 9FR X 4" (10 CM)

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code FOZ·August 17, 2020

ARROW PSI SET: 9 FR

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code DYB·November 2, 2020

ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code DYB·September 27, 2021

ARROW MULTI-LUMEN/PSI SET

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code FOZ·March 24, 2020

ARROW PSI SET: 9 FR

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code DYB·October 11, 2019

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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