12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The Alma Hybrid Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283112·DEAVER RETRACTOR HOLLOW 1" X 10"
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192305·Revision Knee Reamer Spiral Fluted - Zimmer 23mm
Dilator
FDA UDI
RZ-Medizintechnik GmbH·04049197514637·Dilator, 2.5 x 230mm
NA
FDA UDI
aap Implantate AG·04042409261374·Cortical Screw 2.5, small head T8, self-tapp. L 30
TRON
FDA 510(k)
FDA Class 2
·Radiology
Arthrex FiberTak Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 14, 2014
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 12, 2011
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 29, 2013
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020