115 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
FDA 510(k)
FDA Class 2
·Microbiology
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
FDA 510(k)
FDA Class 2
·Microbiology
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
FDA 510(k)
FDA Class 2
·Microbiology
THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
FDA 510(k)
FDA Class 2
·Microbiology
cobas liat SARS-CoV-2 v2 nucleic acid test
FDA 510(k)
FDA Class 2
·Microbiology
CTS-3060 AUTOMATED SEMEN ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
SPERMCHECK VASECTOMY
FDA 510(k)
FDA Class 2
·Hematology
LensHooke X12 PRO Semen Analysis System
FDA 510(k)
FDA Class 2
·Hematology
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
FDA 510(k)
FDA Class 2
·Hematology
SQA, SPERM QUALITY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
SwimCount Sperm Quality Test
FDA 510(k)
FDA Class 2
·Hematology
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Trak Male Fertility Testing System
FDA 510(k)
FDA Class 2
·Hematology
FERTELL MALE FERTILITY TEST
FDA 510(k)
FDA Class 2
·Hematology
Modified Novy Cornual Cannulation Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
YO Home Sperm Test
FDA 510(k)
FDA Class 2
·Hematology
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
FDA 510(k)
FDA Class 2
·Hematology
SQA-iOw Sperm Quality Analyzer
FDA 510(k)
FDA Class 2
·Hematology