13 results
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27ms
·
Sources: EU EUDAMED, US FDA
WAVE GATE
FDA 510(k)
FDA Class 2
·Neurology
Empower Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746122002·DB BKT SL EMPOWER PASSIVE LL 1ST BIC 022 T-12 A...
Empower2
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746013119·DB BKT SL EMPOWER PASSIVE LL 1ST BIC 022 T-12 A...
Empower2
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746010460·DB BKT SL EMPOWER INTERACT LL 1ST BIC 022 T-12 ...
Empower Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746072093·DB BKT SL EMPOWER INTERACT LL 1ST BIC 022 T-12 ...
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746047619·WIRE SS GOLD TONE LOWER 012 BONWILL HAWLEY 100/PK
CENTERPIECE™ Plate Fixation System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902427350·PLATE 853-412 12MM GRFT PLT
FLEXISCOPE, MODELS 50MH AND 50 MHC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Sleep Profiler
FDA 510(k)
FDA Class 2
·Neurology
COMPRESSOR MINI
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code BTI·April 4, 2014
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·November 30, 2012
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·September 27, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024