24 results · 29ms · Sources: EU EUDAMED, US FDA

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Dentiq3D

FDA 510(k)
FDA Class 2 ·Radiology

CAROTID ACCESS KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

KHAN KINETIC TREATMENT (KKT-M2)

FDA 510(k)
FDA Unclassified ·Unknown

BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 22 GA 1.00 IN

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 13, 2023

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013

DUAL TRIGGER ROTARY

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 30, 2011

POLYFLUX R CAPILLARY DIALYZER

FDA Adverse Event
Other ·GAMBRO DIAYLSATOREN GMBH·Product code KDI·July 11, 2008

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 26, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 9, 2023

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx

FDA Enforcement
Class II ·Ongoing·Enchroma Inc·November 27, 2024

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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