15 results · 22ms · Sources: EU EUDAMED, 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