28 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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Flex-Thread Distal Fibula lntramedullary Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
DVX5.5 SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809228126613·Rod, Ø5.5 x 300mm
MEGA5.5 SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809228125821·Rod, Ø5.5 x 300mm
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247171·No-Profile Interbody, 35mm x 27mm x 20mm, 30 Deg
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730007551·Votion 018 MC U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315819108·XCyte 12, XCyting Human Mulicolor Band Probe
PORTABLE INTENSIVE CARE UNIT
FDA 510(k)
FDA Class 3
·Cardiovascular
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INSYTE AUTOGUARD GN 18GA X 1.16IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 25, 2021
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
ETHICON
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY INC·Product code GDO·October 24, 2008
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011
NA
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code NLQ·July 8, 2013
8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
JUGGERKNOT 1.4MM SHRT W/NDLS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·November 19, 2025
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023
22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
7MM TI STRAIGHT RADIAL STEM 26MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017