14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5
FDA 510(k)
FDA Class 1
·Ophthalmic
GC Initial™
FDA UDI
Gc America Inc.·J0228702031·GC Initial™ MC Bleach Dentin- white, BLD-2, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556700577·GC Initial™ MC Bleach Dentin- white, BLD-2, 20g
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78702031·Mini Sprint Bracket Roth .018" max. 2 left
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022223·CAST 5DEG LFM CONV B/T -22TRQ 022 LT
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78702030051·Mini Sprint Bracket Roth .018" max. 2 left
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78702030101·Mini Sprint Bracket Roth .018" max. 2 left
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78702031001·Mini Sprint Bracket Roth .018" max. 2 left
System, Applicator, Radionuclide, Remote Controlled
FDA 510(k)
FDA Class 2
·Radiology
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
FDA 510(k)
FDA Class 2
·General Hospital
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 12, 2014
VITROS 5,1 FS CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·October 15, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·December 12, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024