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