11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Hemostatic Clips
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103067·DONNENFELD FEMTO SPLITTER RIGHT
Keos Anterior Cervical Interbody Fusion Device System
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
FDA 510(k)
FDA Class 2
·Dental
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·May 12, 2025
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·November 13, 2020
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL·Product code FRN·October 24, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 25, 2011
GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 18, 2013
GSOURCE, LLC
FDA Adverse Event
Malfunction
·GSOURCE, LLC·Product code HTW·January 7, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020