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

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SILVERLON CONTACT WOUND DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

MICROSPEED EC MOTORSYSTEM GD650/GD653

FDA 510(k)
FDA Class 2 ·Neurology

INCARE PELVIC FLOOR THERAPY SYSTEM

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

ApeCord

FDA UDI
RIVERPOINT MEDICAL, LLC·00840277409812·White/Black UHMWPE Polyblend Non-Absorbable Suture

ApeCord

FDA UDI
RIVERPOINT MEDICAL, LLC·00840277409805·Black UHMWPE Polyblend Non-Absorbable Suture

ApeCord

FDA UDI
RIVERPOINT MEDICAL, LLC·00840277409799·White/Black UHMWPE Polyblend Non-Absorbable Suture

ApeCord

FDA UDI
RIVERPOINT MEDICAL, LLC·00840277409782·Black UHMWPE Polyblend Non-Absorbable Suture

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 28, 2025

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·March 27, 2013

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Other ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·January 7, 2011

ACRYSOF TORIC

FDA Adverse Event
Other ·ALCON RESEARCH, LTD./ HUNTINGTON·Product code HQL·March 28, 2008

EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

FDA Adverse Event
Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code PSV·March 14, 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

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018