11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
FDA 510(k)
FDA Class 2
·Anesthesiology
MAGNUM INSTRUMENTATION
FDA UDI
Biomet Uk Ltd·05019279440474·
M2a-Magnum™
FDA UDI
Biomet Orthopedics, LLC·00887868474392·
REPROCESSED RESTEP COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINITY GAMMA
FDA 510(k)
FDA Class 2
·Cardiovascular
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NKM·October 3, 2014
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 21, 2011
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·November 10, 2021