17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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