23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106100·Trial, 26 x 10mm, 8 Degree, Tapered, Straight
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151439·Endo Carry-on Procedure Kit contains Intercept ...
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890106100·Zirlux Bite Ver Cyl Engage
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033181812·
HYDROFIX VASO SHIELD, MODEL HVS-001-0610
FDA 510(k)
FDA Class 2
·Cardiovascular
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100100·Tab Breaker, Offset Dbl End Assembly
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0100100·Caddie, Lid, Plates & Screws
RESOLUTION CHOLESTEROL MONITOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TESS GLENOID REVERSE HEAD DIAMETER 36
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·March 19, 2013
ENDURANT AUI STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·March 1, 2011
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
BLUNT TIP SCREW, 4X50MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 6, 2020
PROXIMAL HUMERUS, RIGHT, 11X160MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 3, 2021
BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 1, 2021
BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 1, 2021
BLUNT TIP SCREW, 4X48MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·September 3, 2021
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025