BELTER INFRA-RED EAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.

FDA 510(k)

FDA Class 2 ·Physical Medicine

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Arthroscopic Electrode (with Pencil)

FDA 510(k)

FDA Class 2 ·Orthopedic

Processor, Cine Film

FDA classification

FDA Class 2 ·Processor, Cine Film

INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RespiraSense

FDA 510(k)

FDA Class 2 ·Anesthesiology

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HealthBeacon HB2 Sharps Bin

FDA 510(k)

FDA Class 2 ·General Hospital

Simple 2 Test

FDA 510(k)

FDA Class 2 ·Microbiology

Kentrospine PSS Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDSYNAPSE Zero Footprint Viewer

FDA 510(k)

FDA Class 2 ·Radiology

CEPTRE® Knotted UHMWPE Suture PEEK Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

STREAMER POLYMER GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular