13 results · 34ms · Sources: EU EUDAMED, US FDA

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COALITION SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

ArgenIS

FDA UDI
ARGEN CORPORATION, THE·D818131449·MUA NC RP 1.5GH Str

MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION

FDA 510(k)
FDA Class 2 ·Orthopedic

INTELLIVUE PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARTICULEZE M HEAD 36MM -2

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·June 19, 2013

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·June 19, 2013

PARIETEX UGYTEX PP 15X10CM X1

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·May 10, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

INGEVITY

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

ASPHERE M SPEC 11/13 36 -3

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·December 11, 2013

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·December 11, 2013

40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025

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