19 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Medipure Oxygen-LC System

FDA 510(k)
FDA Class 1 ·Anesthesiology

LEONE SPA

FDA UDI
LEONE SPA·08033707015109·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 18

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828186780·GEN4 INTERACTIVE

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383507677·Gutta Percha Points is used to root canal filin...

TRINITY ACETABULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CLEARLINK PACLITAXEL SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 6, 2026

SEE H10

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

DUO-VENT CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 12, 2023

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

FORTIFY ST VR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014

SPRINT QUATTRO

FDA Adverse Event
Malfunction ·MPRI·Product code LWS·June 8, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

VALEO / VALEO II

FDA Adverse Event
Malfunction ·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021