BANTAM,48XXXXXX, 50XXXXXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

BANTAM CATHETER (280MM BALLOON LENGTHS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLEEK OTW PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%

FDA 510(k)

FDA Class 2 ·Ophthalmic

MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cliniview

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)

FDA 510(k)

FDA Class 2 ·Orthopedic

E-EEGX, N-EEGX

FDA 510(k)

FDA Class 2 ·Neurology

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIVASCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450, E-musb

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steriking® LT-Blueline Pouches with Tyvek®

FDA 510(k)

FDA Class 2 ·General Hospital

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

FDA 510(k)

FDA Class 2 ·Anesthesiology

Icare ic100

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Steriking LT-Blueline Pouches with Tyvek

FDA 510(k)

FDA Class 2 ·General Hospital

PLANMED NUANCE DIGIGUIDE

FDA 510(k)

FDA Class 2 ·Radiology