12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE SUTURE REMOVAL SCISSORS
FDA 510(k)
FDA Class 1
·General Hospital
ARx SAI
FDA UDI
Life Spine, Inc.·00190837189112·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837190583·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837173647·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837173043·
CD HORIZON(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANTA 2 BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·April 17, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MMI·August 24, 2010
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015