9 results · 22ms · Sources: EU EUDAMED, US FDA

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GRI LASERGRAPH(TM) ECG PAPER

FDA 510(k)
FDA Class 1 ·Cardiovascular

IVAC VENTED/UNVENTED TUBING

FDA Adverse Event
ALARIS MEDICAL SYSTEMS, INC.·Product code FPA·July 15, 1999

MEDPOR PTERIONAL SURGICAL IMPLANT

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

MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CLARION IMPLANT

FDA Adverse Event
Malfunction ·ADVANCED BIONICS LLC·Product code MCM·May 9, 2014

CURRENT RF DR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 8, 2013

WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·November 18, 2010

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

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