9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA LITE RF IGG ELISA
FDA 510(k)
FDA Class 2
·Immunology
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983083·posteriors; shade C2; size L; lower jaw
Shoreline Cervical Interbody RT System
FDA 510(k)
FDA Class 2
·Orthopedic
AGILIS NXT STEERABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Zimmer, Inc.·00889024218789·
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·February 28, 2013
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·August 6, 2014
KEYLSS LAG SCR STD 90MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KTT·February 4, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024