71 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HealthFLD
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 29, 2025
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·November 12, 2024
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 26, 2011
ADAPTER SLEEVE 11/13 +0
FDA Adverse Event
Malfunction
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 18, 2013
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·May 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·April 20, 2026
COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·March 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·April 22, 2026
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·January 9, 2025
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 29, 2020
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·March 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·May 12, 2026
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·September 12, 2024
COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 8, 2025
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·August 12, 2025