14 results
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26ms
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Sources: EU EUDAMED, US FDA
SUCTION INSTRUMENT, MACBICK POOLE TIP
FDA 510(k)
FDA Class 2
·General Hospital
ILIF
FDA UDI
Nuvasive, Inc.·00887517263391·ILIF Trial, 16mm
Ceramill® ZI
FDA UDI
Amann Girrbach AG·E4947602161·
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471178584·Anatomical Molar Bands, Upper Right 1St & 2Nd M...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110560·COAXIAL IRRIGAT-ASPIRAT TIP STR 0.4 PORT
Daytona Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981152628·Fixed Crossbar, 4.5 x 16mm
Revolution Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
K760216D
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Realy Tech Co.,Ltd.·1 device
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 26, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 8, 2015
RESIDENT BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 12, 2010
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021