207 results
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16ms
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Sources: EU EUDAMED, US FDA
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Fda510k
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GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
FDA 510(k)
FDA Class 1
·Microbiology
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
FDA 510(k)
FDA Class 2
·Hematology
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CORATOMIC #VX5-105 & VX5-205 PULSE GEN.
FDA 510(k)
FDA Class 3
·Cardiovascular
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
FDA 510(k)
FDA Class 3
·Cardiovascular
Contour® next GEN Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FIELD MEDICAL OXYGEN GEN/DIST SYS-BATTLEFIELD PURP
FDA 510(k)
FDA Class 2
·Anesthesiology
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242
FDA 510(k)
FDA Class 3
·Cardiovascular
ISE INDIRECT NA, K, C1 FOR GEN 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS
FDA 510(k)
FDA Class 1
·Microbiology
ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.
FDA 510(k)ISE INDIRECT NA, K, CL FOR GEN.2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SINEXUS SINUS STENT GEN 2, MODEL 1999-25
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
CONTOUR® NEXT GEN Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
FDA 510(k)
FDA Class 2
·Cardiovascular