16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURACON BASEPLATES
FDA 510(k)
FDA Class 2
·Orthopedic
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9360081·Retention Cap, universal
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0360080·Compressor, Modular Tip
PINNACLE 3
FDA 510(k)
FDA Class 2
·Radiology
COAT-A-COUNT INTACT PTH IRMA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
Zimmer, Inc.·00889024078338·
NA
FDA UDI
Zimmer, Inc.·00889024104174·
NA
FDA UDI
Zimmer, Inc.·00889024104167·
NA
FDA UDI
Zimmer, Inc.·00889024078345·
NA
FDA UDI
Zimmer, Inc.·00889024104150·
NA
FDA UDI
Zimmer, Inc.·00889024078352·
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·January 20, 2016
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 30, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 22, 2010
INGEVITY
FDA Adverse Event
Malfunction
·CPI PLANT - ST. PAUL·Product code NVN·July 15, 2014
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HRS·December 9, 2015