Custom Healthcare Systems Inc.

FDA UDI

Manus Medical, LLC·00811870032370·

CUSTOM MEDICAL SUSPENSION STRAP

FDA 510(k)

FDA Class 1 ·Anesthesiology

STERILE PHYSIOLOGICAL SALINE/STERILE WATER

FDA 510(k)

FDA Class 2 ·General Hospital

SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

FDA 510(k)

FDA Class 2 ·Orthopedic

CUSTOM PROCEDURE TRAYS

FDA 510(k)

FDA Class 2 ·General Hospital

CATHETER INSERTION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

TEFGEN-FD

FDA 510(k)

FDA Class 2 ·Dental

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC

FDA 510(k)

FDA Class 2 ·Cardiovascular

CUSTOM OPTICAL SUNGLASS FRAMES

FDA 510(k)

FDA Class 1 ·Ophthalmic

MODEL 3000 HYPERBARIC CHAMBER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC

FDA 510(k)

FDA Class 2 ·General Hospital

PELVIC EXAM TRAY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ArthrexVIP Web Portal

FDA 510(k)

FDA Class 2 ·Radiology

CATHETER INSERTION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

SUCTION CANNULAS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

REUSABLE TOWEL AND GOWN PACKS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CSPI PREMIUM SURGICAL ASPIRATOR

FDA 510(k)

REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat