ADHEAR System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

FDA 510(k)

FDA Class 2 ·General Hospital

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Valiant Curing Light

FDA 510(k)

FDA Class 2 ·Dental

Disposable Endoscope Valve Sets

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ali Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE

FDA 510(k)

FDA Class 2 ·Orthopedic

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VERSA STIM 380, MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

PROSTHETIC - FEMORAL HIP COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DYNATRAC

FDA 510(k)

FDA Class 2 ·Physical Medicine

STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

KONUS DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)

FDA 510(k)

FDA Class 2 ·General Hospital