17 results · 24ms · Sources: EU EUDAMED, US FDA

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All Poly Tibial Component

FDA 510(k)
FDA Class 2 ·Orthopedic

1.5 LACTOSORB SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036055707·

OsteoMed

FDA UDI
OSTEOMED LLC·00842528127643·2.4 X 30mm Cannulated Headless Screw, T7

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741524300·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674152430060·

TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

DS2ADV AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·April 6, 2024

LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

LIFEPAK(R) 1000 DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

BD Q-SYTE VIAL ACCESS ADAPTER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·February 14, 2025

SELECTOR 35KHZ NEURO HANDPIECE

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES, LTD.·Product code LFL·October 3, 2014

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 28, 2011

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024