20 results · 24ms · 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.

U-Lite

FDA 510(k)
FDA Class 2 ·Radiology

StabiliT Second Fracture Kit

FDA UDI
Dfine, Inc.·00850696006400·

BD MICRO FINE PLUS¿ PEN INJECTOR NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 20, 2018

StabiliT®

FDA UDI
Merit Medical Systems, Inc.·00884450379837·

StabiliT®

FDA UDI
Merit Medical Systems, Inc.·00884450315927·

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PEN NDL 32G 4MM PRO 100 BOX 1200 CA

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 6, 2024

PEN NDL 32G 4MM PRO 100 BOX 1200 CA

FDA Adverse Event
Malfunction ·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·March 20, 2024

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code ITI·October 6, 2014

PINNACLE PELVIC FLOOR REPAIR KITS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013

SM104 M-SERIES W/5TH WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·June 2, 2011

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

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

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

ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

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

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026