13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AUTION ELEVEN Semi-Automated Urinalysis System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...
VIVID POST DRILL
FDA UDI
BIOLOREN SRL·08056099233340·Cylindrical drill ø 1.2 mm.
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....
ESI
FDA UDI
FTT MEDICAL, INC.·B3961600620·YANKAUER SUCTION TUBE, PEDIATRIC SIZE. ACMI FIT...
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450046456·
INFILTRATION KIT
FDA 510(k)
FDA Class 2
·Dental
STRAUMANN ORTHOSYSTEM
FDA 510(k)
FDA Class 2
·Dental
PRISMAFLEX M100 SET
FDA Adverse Event
Injury
·GAMBRO INDUSTRIES·Product code KDI·October 10, 2014
AUTOLUBE-III WITH IRRIGATION
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
MAGNETOM Verio Dot. Model Number: 10684333.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014