10 results · 28ms · Sources: EU EUDAMED, US FDA

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KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking

ACE VERSANAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

ACTIS ADJUSTABLE CONSTRICTION LOOP

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

METRX® SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HRX·December 10, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

BRAT2 RESERVOIR W/OUTLET CLAP 30MCG FILTER

FDA Adverse Event
Injury ·SORIN GROUP·Product code DXE·September 10, 2014

STENOSCOP

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·May 3, 2011

METRX® SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·October 18, 2024

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