12 results · 22ms · Sources: EU EUDAMED, US FDA

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FairFix QT Adjustable Button

FDA 510(k)
FDA Class 2 ·Orthopedic

Ryno Lacer Wrist and Thumb Support

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357237951·

PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

AXON-BUS PROSTHETIC SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 22, 2025

INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 22, 2025

INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 22, 2025

TENDRIL SDX

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 18, 2011

DUROM ACETABULAR COMPONENT 52/46 CODE L

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWA·July 10, 2013

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026