55 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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PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
Bur PM2-70 50K Diam Ø2.7x80
FDA UDI
Bien-Air Surgery SA·17630055514742·
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994154873·SCREW 8100845 BREAKOFF SET SCRW 10-32
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964056864·Endo Carry-On Procedure Kit
MAXCUT DIAMOND BURS (6/pk) MED 845-014
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100845141·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...
Monoblock Tibial Trial UC Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043391·
Zavation
FDA UDI
Zavation LLC·00197157002213·4.5mm Cannulated Tap
MAXCUT DIAMOND BURS (6/pk) MED 845-016
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100845161·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...
MAXCUT DIAMOND BURS (6/pk) MED 845-009
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100845091·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...
MAXCUT DIAMOND BURS (6/pk) MED 845-021
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100845211·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981045883·LATERAL IMPLANT, STANDARD SPINPLATE™, 8mm X 45mm
ZAVATION
FDA UDI
Zavation LLC·00842166189737·Tap, Angled 4.5mm
MAXCUT DIAMOND BURS (6/pk) MED 845-012
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100845121·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...
UA Temporization Sleeve
FDA UDI
BICON, LLC·00813110027047·UA4 SP-TP Temporization Sleeves (3)
MAXCUT DIAMOND BURS (6/pk) MED 845-010
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100845101·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...
MODIFICATION TO OSTEONICS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
Widex
FDA UDI
Widex A/S·05706069773613·Widex EVOKE E-FA (Shocking pink S-440 ) Telecoi...