17 results · 28ms · Sources: EU EUDAMED, US FDA

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ANTRUM & ATTIC MIRROR

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

LABONE MICRO-PLATE COTININE EIA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 27, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 29, 2012

2 GALLON SHARPS CONTAINER

FDA Adverse Event
Injury ·MEDEGEN·Product code MMK·September 7, 2010

ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015

ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·December 19, 2014

ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·November 1, 2016

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 29, 2016

RP FLEX W SMART ASSIST SET, US

FDA Adverse Event
Death ·ABIOMED, INC. - 1220648·Product code PYX·February 21, 2026

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·June 15, 2016

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH·Product code KNT·June 12, 2024

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·August 30, 2016

Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018