TDM Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

PathLoc SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

XERO-alpha

FDA 510(k)

FDA Class 2 ·Dental

SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXPD 4343P, EXPD 3643P

FDA 510(k)

FDA Class 2 ·Radiology

EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG

FDA 510(k)

FDA Class 2 ·Radiology

Hair Up

FDA 510(k)

FDA Class 2 ·Physical Medicine

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

FDA 510(k)

FDA Class 2 ·Radiology

CastleLoc-S Posterior Cervical Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Sonix Health

FDA 510(k)

FDA Class 2 ·Radiology

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

FDA 510(k)

FDA Class 2 ·Radiology

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OLIZ LTB-1000A

FDA 510(k)

FDA Class 2 ·Physical Medicine

ARIX Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

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