15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAT FAX(TM)-2100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
XLIF
FDA UDI
Nuvasive, Inc.·00887517626950·XLIF Cobb, 18mm Suction
3M™ Unitek™
FDA UDI
3M COMPANY·30605861027718·3M™ Unitek™ Stainless Steel Second Primary Mola...
NA
FDA UDI
Stryker GmbH·00886385022338·Sigmoid Notch Screw
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981129255·Screw Shank Driver, Locking, Long
Young Specialties
FDA UDI
Young Innovations, Inc.·00843471189160·Comfort Hook™ Weldable Non-Convertible Buccal T...
FLUROPERM 60-OK, PARAGON HDS-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
FORTEX PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINER FOR METAL BACK GLENOID STANDARD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·November 7, 2022
COBAS® HIV-1
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code MZF·August 28, 2025
ENDO ILS, 29MM, CURVED
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2014
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 7, 2013
TA 30-4.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·November 10, 2010
3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
FDA Enforcement
Class III
·Terminated·3M Company - Health Care Business·December 4, 2013
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
FDA Enforcement
Class II
·Ongoing·Scientia Vascular, Inc.·March 22, 2023