606 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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FilmArray Pneumonia/Pneumoniaplus Control
FDA 510(k)
FDA Class 2
·Microbiology
BioFire JI Control Panel M420
FDA 510(k)
FDA Class 2
·Microbiology
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
FDA 510(k)
FDA Class 2
·Microbiology
Cepheid Xpert MRSA NxG Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
BD MAX CT/GC/TV 20-Day QC Panel
FDA 510(k)
FDA Class 2
·Microbiology
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
FDA 510(k)
FDA Class 2
·Microbiology
Cepheid Xpert SA Nasal Complete Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
Cepheid Xpert C. difficile/Epi Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
Cepheid Xpert Respiratory Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray Global Fever Panel External Control Kit
FDA 510(k)
FDA Class 2
·Microbiology
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
FDA 510(k)
FDA Class 2
·Cardiovascular
745-M (MAGNUM)
FDA 510(k)
FDA Class 2
·Physical Medicine
SAHARA SUNBED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
R1363 PARAFFIN
FDA 510(k)
FDA Class 2
·Physical Medicine
TREATMENT TABLE
FDA 510(k)
FDA Class 2
·Radiology
WHEELCHAIR MODEL STS
FDA 510(k)
FDA Class 2
·Physical Medicine
HI-LO TABLE, MODEL 820-05
FDA 510(k)
FDA Class 2
·Physical Medicine
R1361 & R1372 MEASURED EXERCISE EQUIPMENT
FDA 510(k)
FDA Class 2
·Physical Medicine
RESPOND(R) Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
MODELS 134, 135 & 136 TRANSFER CART/TABLE
FDA 510(k)
FDA Class 2
·Physical Medicine