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

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Total Bilirubin

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CoRoent

FDA UDI
Nuvasive, Inc.·00887517566461·CoRoent Ant TLIF PEEK, 15x12x34mm 4°

LACTOSORB SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036055363·

COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C

FDA 510(k)
FDA Class 2 ·Radiology

MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

CARELINK

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code KRG·June 7, 2013

COLLEAGUE PRE 1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 12, 2017

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 27, 2016

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 10, 2017

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 10, 2017

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024