15 results · 21ms · Sources: EU EUDAMED, US FDA

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DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER

FDA 510(k)
FDA Class 2 ·Ophthalmic

ORIGEN DUAL LUMEN CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E

FDA 510(k)
FDA Class 1 ·General Hospital

TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

LTV 1200 VENTILATOR

FDA Adverse Event
Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·November 13, 2023

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·April 9, 2026

TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code DZL·September 6, 2017

STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code HXX·April 29, 2013

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·April 13, 2011

BIOSYN 4/0

FDA Adverse Event
Injury ·NORTH HAVEN - USS·Product code GAN·July 28, 2008

TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

LTV 1200 VENTILATOR

FDA Adverse Event
Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·December 13, 2023

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024