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

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N PROTEIN STANDARD UY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CD 3700 SL

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007

PRIMER PLUS

FDA 510(k)
FDA Class 2 ·Dental

OptikView GUP2103CMI

FDA 510(k)
FDA Class 2 ·Radiology

MICROTAINER SST GOLD

FDA Adverse Event
Malfunction ·BD CARIBE LTD.·Product code JKA·June 7, 2018

BD MICROTAINER® EDTA LAVENDAR TUBES

FDA Adverse Event
Malfunction ·BD CARIBE LTD.·Product code JKA·May 1, 2018

BD MICROTAINER® EDTA LAVENDAR TUBES

FDA Adverse Event
Malfunction ·BD CARIBE LTD.·Product code JKA·May 16, 2018

MICROTAINER SST GOLD

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD·Product code JKA·May 7, 2018

BD MICROTAINER® EDTA LAVENDER TUBES

FDA Adverse Event
Malfunction ·BD CARIBE LTD.·Product code JKA·April 27, 2018

BD MICROTAINER® EDTA LAVENDAR TUBES

FDA Adverse Event
Malfunction ·BD CARIBE LTD.·Product code JKA·May 3, 2018

BD MICROTAINER® BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BD CARIBE LTD.·Product code JKA·December 3, 2017

CELL-DYN 3700 SL ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 6, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA INC.·Product code LWP·August 8, 2014

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025