Synapse PACS

FDA 510(k)

FDA Class 2 ·Radiology

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System

FDA 510(k)

FDA Class 2 ·Microbiology

VCS S3T

FDA 510(k)

FDA Class 2 ·Physical Medicine

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

FDA 510(k)

FDA Class 2 ·Microbiology

MAMMOGRAPHY VIEWER SMV658

FDA 510(k)

FDA Class 2 ·Radiology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

VCS, MODEL S4T

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0

FDA 510(k)

FDA Class 2 ·Radiology

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS

FDA 510(k)

FDA Class 2 ·Radiology

FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL

FDA 510(k)

FDA Class 2 ·Ophthalmic

Project E Beauty LED Light Therapy Mask (Model: PE730)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SOFT-55 DAILY WEAR CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

UCEZ - STERILE LENS FOG REDUCTION DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FOG CONTROL, LENS FOG REDUCTION DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TROKEL SINGLE MIRROR YAG LASER LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic