11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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t:slim Insulin Delivery System
FDA 510(k)
FDA Class 2
·General Hospital
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084837·K-Wire, Double Ended, Trocar Point, Diameter 0....
VIVID POST TRANSLUCENT
FDA UDI
BIOLOREN SRL·08056099233265·Cylindrical fiberglass light transmitting posts...
MEDCOM RT-VIEWER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AFINION ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
BAROUK SCREW - 3 0MM X 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·April 7, 2020
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
5.0 CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES·Product code HBC·June 10, 2013
REVEAL LINQ
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code DSI·October 10, 2014
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