DIA-ROOT BIO MTA

FDA 510(k)

FDA Class 2 ·Dental

Diafil & Diafil Capsule

FDA 510(k)

FDA Class 2 ·Dental

DiaTemp Flow

FDA 510(k)

FDA Class 2 ·Dental

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

MICHELE SLEEP SCORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CPAP Cannulaide

FDA 510(k)

FDA Class 2 ·Anesthesiology

HAND HELD NEBULIZER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A

FDA 510(k)

FDA Class 2 ·Immunology

SALTER LABS PEP DEVICE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPQ TEST SYSTEM FOR HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology