13 results · 19ms · Sources: EU EUDAMED, US FDA

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BruxZir NOW

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743755·ACHIMED ACHILLES SUPP SAND VI

IRON-PC-SL ASSAY MODEL # 151-10, 151-26

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

INZONE DETACHMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD MICROLANCE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·January 17, 2024

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·October 30, 2008

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·August 23, 2011

URETERAL CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code GBM·July 11, 2013

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 27, 2019

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025