13 results · 29ms · Sources: EU EUDAMED, US FDA

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PD CASTA-H

FDA 510(k)
FDA Class 2 ·Dental

DW 273 #1

FDA 510(k)
FDA Class 2 ·Dental

0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE

FDA 510(k)
FDA Class 2 ·General Hospital

ERBE

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 2, 2022

PS

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·April 2, 2013

NEXGEN LEGACY KNEE LPS ARTICULAR SURFACE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·March 18, 2011

CLEARSTAR PUMP

FDA Adverse Event
Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·April 15, 2008

ERBE

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·March 8, 2023

ERBE

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·February 18, 2025

ATTUNE CR FEM LT SZ 7 CEM

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code JWH·September 17, 2022

ERBE

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code GEI·July 27, 2022

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

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013