77 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1220300·12mm H x 20mm W x 30mm L x 0 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741220300·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X122030120·12mm H x 20mm W x 30mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X12203080·12mm H x 20mm W x 30mm L x 8 degrees XLIF
FAC-3 - Class B BMD 21 - 3 Shelf
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620305·FAC-3 - Class B BMD 21 - 3 Shelf
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L122030120·12mm H x 20mm W x 30mm L XLIF Trial 12 degree L...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1220100·Breaker, Extended Tab
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674122030060·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321220300·
POLY-CARB
FDA 510(k)
FDA Class 2
·Dental
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
3I T3® TAPERED IMPLANT 4/3 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·May 20, 2025
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 9, 2011
ASR ACETABULAR IMPLANT 44
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 21, 2013
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-3.5
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 14, 2008
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·December 20, 2023
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·June 22, 2018
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·March 29, 2016