308 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
FDA 510(k)
FDA Class 2
·Radiology
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
FDA 510(k)
FDA Class 2
·Orthopedic
Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
FDA 510(k)
FDA Class 2
·Neurology
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
FDA 510(k)
FDA Class 2
·Microbiology
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE
FDA 510(k)
FDA Class 2
·Microbiology
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·USCI GRUNTZIG DILACA CATHETER
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX HBsAg Qual assay and Control
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS TAQMAN HCV TEST VERSION 2.0
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Alinity m HCV