9 results
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21ms
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Sources: EU EUDAMED, US FDA
iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
FDA 510(k)
FDA Class 2
·Microbiology
FORWARD CUTTING MONOBLOC REAMER, HUDSON, Ø8.5mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665001198·
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251085200·ceraMotion® Ti Shoulder white, 20 g / dental ce...
NeVa PV Thrombectomy Device
FDA 510(k)
FDA Class 2
·Cardiovascular
DOPPLER-BOX
FDA 510(k)
FDA Class 2
·Radiology
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·November 14, 2014
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 29, 2013
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024