18 results · 21ms · Sources: EU EUDAMED, US FDA

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Electric Scooter (Model: S3312)

FDA 510(k)
FDA Class 2 ·Physical Medicine

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA UDI
FX SOLUTIONS·03701037318102·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY ...

Signature ONE System

FDA 510(k)
FDA Class 2 ·Orthopedic

INFINITY EXPLORER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·August 11, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 6, 2014

COULTER® LH 780 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·July 16, 2013

VITEK® REVEAL¿ SENSOR PANEL

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

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 17, 2024

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Vue Motion V12. Product Number: 1017979.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

CODMAN Disposable Perforator, 14mm. Cranial perforator.

FDA Enforcement
Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021