29 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HemoCue® Glucose 201 DM Analyzer
FDA UDI
Hemocue AB·07311091214225·HemoCue Glucose 201 DM Analyzer mg/dL plasma
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508208·
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249271·PrimePadPlus-K12-3422
MaxFuse VBR, 10 (D) x 12 (W) x 44 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055424·10 (D) x 12 (W) x 44 (H)
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
FDA 510(k)
FDA Class 2
·Cardiovascular
Zavation
FDA UDI
Zavation LLC·00842166122697·Cage - 12x14mm, 22-34mm, 5°
Zavation
FDA UDI
Zavation LLC·00842166122703·Cage - 12x14mm, 22-34mm, 10°
Zavation
FDA UDI
Zavation LLC·00842166122710·Cage - 12x14mm, 22-34mm, 15°
Zavation
FDA UDI
Zavation LLC·00842166122680·Cage - 12x14mm, 22-34mm, 0°
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·February 20, 2025
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929059463·Convexx Corpectomy, 12Dx14Wx22H, 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034125·Corpectomy, 12Dx14Wx22H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034316·Corpectomy, 12Dx14Wx22H 6°
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
ACCRUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 28, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·June 7, 2011
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
PERITX DRAINAGE BAG KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·December 18, 2025