I/A/KPE TIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

WALLACE INTRAUTERINE INSEMINATION CATHETER

FDA 510(k)

FDA Class 2 ·Dental

BladderScan Prime System

FDA 510(k)

FDA Class 2 ·Radiology

HydroMARK Breast Biopsy Site Markers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PENTAX Medical EKP-i5010 Video Processor with EB Family

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CAPERE Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRANSPARENT ANESTHESIA FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PARTNER INFUSION SYSTEM:

FDA 510(k)

FDA Class 2 ·General Hospital

EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS

FDA 510(k)

FDA Class 2 ·General Hospital

HM70 EVO Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

STERiJECT Low Dead Space, STERiJECT The Invisible Needle

FDA 510(k)

FDA Class 2 ·General Hospital

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

FDA 510(k)

FDA Class 2 ·General Hospital

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE (Colors & Flavors), SKORE (Colors)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SINGLE PATIENT SYSTEMS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology