14 results
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18ms
·
Sources: EU EUDAMED, US FDA
HOPE MODEL 126, AUTO/PROCES., DEN. FLM
FDA 510(k)
FDA Class 1
·Radiology
Helix
FDA UDI
Nuvasive, Inc.·00887517134967·Helix R Plate, 34mm 1-Level
THD N-ano anoscope
FDA UDI
THD SPA·08033737710708·The THD N-ano anoscope is a disposable medical ...
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209101498·KIT, OPERATOR STORM/IFAK - ODG
ACUMED
FDA UDI
Acumed LLC·10806378040177·Uni. Tray Lkg. Foot Plate Insert Lid
EYEVAN7285
FDA UDI
EYEVAN INC.·04571445021067·
Jimushi Sterile Urethral Catheter for single use
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
FDA 510(k)
FDA Class 2
·Physical Medicine
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 8, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·August 10, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021