2,771 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
FDA 510(k)
FDA Class 2
·Microbiology
BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
FDA 510(k)
FDA Class 2
·Microbiology
COMPUTERIZED LABOR MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
FDA 510(k)
FDA Class 2
·Microbiology
RETROX
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
HEM-AVERT PERIANAL STABILIZER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NUCLEUS-X PTV CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND
FDA 510(k)
FDA Class 2
·Neurology
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR
FDA 510(k)
FDA Class 2
·General Hospital
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
XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
FDA 510(k)
FDA Class 2
·Microbiology
ILLUMINA MISEQDX PLATFORM
FDA 510(k)
FDA Class 2
·Immunology
DIAMOND PROBE/PERIO 2000 SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Blood Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROLET®NEXT 2 Lancing Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Accu-Chek FastClix Blood Lancing System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Lancing device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery