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

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AutoContour Model RADAC V3

FDA 510(k)
FDA Class 2 ·Radiology

Philips

FDA UDI
Sbo Hearing A/S·05714464032648·HEARLINK 7030 MNR T GR/DG

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TEETH IN AN HOUR - ARK IMPLANT CONCEPT

FDA 510(k)
FDA Class 2 ·Dental

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·November 6, 2014

CARDIOROOT WOVEN VASCULAR GRAFT

FDA Adverse Event
Injury ·INTERVASCULAR·Product code DSY·August 12, 2011

LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code NKB·July 16, 2013

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

VITEK® REVEAL¿ SENSOR PANEL

FDA Adverse Event
Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·January 31, 2024

VITEK® REVEAL¿ SENSOR PANEL

FDA Adverse Event
Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

VITEK® REVEAL¿ SENSOR PANEL

FDA Adverse Event
Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

VITEK® REVEAL¿ SENSOR PANEL

FDA Adverse Event
Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

VITEK® REVEAL¿ SENSOR PANEL

FDA Adverse Event
Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025