The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

bright CT

FDA 510(k)

FDA Class 2 ·Radiology

HS40 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PEAK NS033CF, PEAK NS017CF

FDA 510(k)

FDA Class 2 ·Dental

POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

AVIEW

FDA 510(k)

FDA Class 2 ·Radiology

rainbow MCT

FDA 510(k)

FDA Class 2 ·Radiology

Estar-ZE

FDA 510(k)

FDA Class 2 ·Dental

ARIX Clavicle System

FDA 510(k)

FDA Class 2 ·Orthopedic

EzDent-i / E2 / Prora View

FDA 510(k)

FDA Class 2 ·Radiology

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);

FDA 510(k)

FDA Class 2 ·Radiology

ARIX Humerus System

FDA 510(k)

FDA Class 2 ·Orthopedic

Ez3D-i / E3

FDA 510(k)

FDA Class 2 ·Radiology

minisono

FDA 510(k)

FDA Class 2 ·Radiology

ARIX Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

BSD3543W

FDA 510(k)

FDA Class 2 ·Radiology

LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

J2A SLA Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

AccelFix Lumbar Expandable Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

KJ ZIRCONIA Implant System

FDA 510(k)

FDA Class 2 ·Dental