10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUSTOM FLANGED ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983035·posteriors; shade A4; size L; lower jaw
Tronex International, Inc.
FDA UDI
TRONEX INTERNATIONAL, INC.·10097604983041·Glove, Exam, Nitrile, Chemotherapy Rated, Finge...
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
FDA 510(k)
FDA Unclassified
·Unknown
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NexGen®
FDA UDI
Zimmer, Inc.·00889024218161·
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 28, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·February 7, 2011
LOANER SYSTEM 6 DT ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·August 6, 2014
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