26 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Latitude
FDA UDI
TORNIER, INC.·00846832015443·RADIAL CUT GUIDE
SourceLink™
FDA UDI
Bard Brachytherapy, Inc.·10801741078153·5.0mm Extension SourceLink™ Connectors
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175061·Z-Rod, Dia. 5.5mm, Titanium, 310mm
VANGUARD DA360 TIBIAL BEARING ARCOM 63/67X18
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 9, 2017
MODIFICATION TO TRIDENT ALL POLY CUP
FDA 510(k)
FDA Class 2
·Orthopedic
VOYAGER 6.0 SOFTWARE OPTION
FDA 510(k)
FDA Class 2
·Neurology
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 20, 2016
I-STAT TROPONIN (HS-TNI ) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code MMI·April 14, 2026
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·March 28, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 7, 2011
HEARTSTREAM XL
FDA Adverse Event
Malfunction
·AGILENT TECHNOLOGIES, INC.·Product code MKJ·April 15, 2008
LOGIC CR TIB INSERT SLOPE++, SZ 1, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·November 22, 2023
COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·May 4, 2026
LOGIC KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 2, 2026
LOGIC CR TIB INSERT STD, SZ 1, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 2, 2026
THREE PEG PATELLA 32MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 2, 2025
LOGIC CR TIB INSERT SLOPE+, SZ 1, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 21, 2023
LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 27, 2023