SURPASSON P5 NEWTRON

FDA 510(k)

FDA Class 2 ·Dental

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA TPU CAL, MODEL A11A01898

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA URINE CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Antibodies, Outer-Membrane Proteins

FDA classification

FDA Class 2 ·Antibodies, Outer-Membrane Proteins

OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS

FDA 510(k)

FDA Class 2 ·Microbiology

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

Reliner, Denture, Over The Counter

FDA classification

FDA Class 2 ·Reliner, Denture, Over The Counter

Valve, Non-Rebreathing

FDA classification

FDA Class 2 ·Valve, Non-Rebreathing

Reprocessed Blood Pressure Cuff

FDA classification

FDA Class 2 ·Reprocessed Blood Pressure Cuff

PRECISION UV(TM) (VASURFILCON A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

PHACO TIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

FM-9000 PLUS FETAL AND MATERNAL MONITOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AQUILEX FLUID CONTROL SYSTEM H112

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODEL 2000 OPHTHALMIC SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic