15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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