Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Lefamulin 0.016- 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Levofloxacin 0.002 - 32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Imipenem 0.016-256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Tetracycline 0.016 - 256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Omadacycline 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Valeda Light Delivery System

FDA 510(k)

FDA Class 2 ·Ophthalmic

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES INSIGHT ULTRASONOMETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS

Mucosal Impedance Measurement System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES