29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113161·LOCATOR R-Tx Abutment for 3.8mm XiVE Connection...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112060·Tap, 8.5 mm
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0112060·Punch, 6 and 8 mm
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 60 mm
FDA UDI
icotec AG·07640164846835·VADER Pedicle System, Rod, Carbon/PEEK, Curved,...
PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMMULITE 2000 SPECIFIC ALLERGENS
FDA 510(k)
FDA Class 2
·Immunology
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2024
PED FOLYSIL CATH 3 ML CH08/5
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code EZL·April 22, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code FPA·April 27, 2011
TUBE, FEEDING ENTERAL W/STYLET 5FR 22IN
FDA Adverse Event
Malfunction
·VIASYS HEALTHCARE MEDSYSTEMS·Product code FPD·June 15, 2008
LINEAR 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 20, 2024
VCL+ VIO 27IN 1 S/A CT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·September 1, 2022
VCL+ VIO 27IN 1 S/A CT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·September 1, 2022
VCL+ VIO 27IN 1 S/A CT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·September 1, 2022
VCL+ VIO 27IN 1 S/A CT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·September 1, 2022