XPERT MTB/RIF ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80

FDA 510(k)

FDA Class 2 ·Microbiology

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

R&G Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHOTON RADIOSURGERY SYSTEM PRS400

FDA 510(k)

FDA Class 2 ·Radiology

NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

cobas® liat CT/NG nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

MAXReach Laser Probe

FDA 510(k)

FDA Class 2 ·Ophthalmic

cobas® liat CT/NG/MG nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

HUMAPEN LUXURA HD

FDA 510(k)

FDA Class 2 ·General Hospital

MEDPOR OCULAR SCREW AND ACCEOSSORIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

TITANIUM PEG SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SEKURE Acetaminophen L3K Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SEKURE HbA1c Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lyograft

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310

FDA 510(k)

FDA Class 2 ·Anesthesiology