13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Low Profile Screws
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550193·GENUMEDI PT KNEE SUP SILVER R EW IV
T PLATE
FDA UDI
Biomet Orthopedics, LLC·00887868004537·
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575234042·Surgical mallet - General Instrument
VACULINK, MODEL VCL 3000
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
FDA 510(k)
FDA Class 2
·Radiology
BD Q-SYTE¿ CLOSED LUER ACCESS PORT - BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·June 19, 2019
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 19, 2026
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DSI·June 3, 2011
PINNACLE SECTOR II CUP 48MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 28, 2008
INTIMA II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 31, 2018