13 results · 21ms · Sources: EU EUDAMED, US FDA

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QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

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

HHM

FDA UDI
Oticon A/S·05707131256300·H160, MINIBTE 312 WL 85 CBE HHM

MBCP

FDA 510(k)
FDA Class 2 ·Orthopedic

CODAN SAFEFEED ENTERAL FEEDING RESERVOIR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

IMP TM 4.7MM MTX FULL, 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 27, 2024

BD NANO¿ 2ND GEN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·July 22, 2022

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVY·October 1, 2014

PRISMAFLEX TPE

FDA Adverse Event
Injury ·GAMBRO INDUSTRIES·Product code LKN·May 29, 2013

ADVIA CENTAUR XP HBSAG ASSAY

FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·June 17, 2011

IMP TM 4.7MM MTX FULL, 10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

IMP TM 6.0MM MTX FULL, 10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 29, 2023

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code HBC·March 26, 2018

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015