11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
FDA 510(k)
FDA Class 2
·Neurology
Trinity Acetabular Hip System
FDA UDI
CORIN LTD·05056139232459·Trinity™ Drill Ø3.2, L 40mm
Deluxe Bariatric Sling - Long Tucks Size 2
FDA UDI
SILVALEA LIMITED·05056387415857·
Deluxe Bariatric Sling - Long Tucks size 1
FDA UDI
SILVALEA LIMITED·05056387415840·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm
SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
FDA 510(k)
FDA Class 2
·Cardiovascular
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
FDA 510(k)
FDA Class 2
·General Hospital
MULTIPOLAR BIPOLAR SHELL
FDA Adverse Event
Injury
·ZIMMER·Product code KWY·January 10, 2013
KAPPA 400 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010
AUROCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DSP·June 9, 2014
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