R. STR Test(L) 48

FDA UDI

SCIMEDX CORPORATION·00813545023034·

STR Muscle Test(L) 96

FDA UDI

SCIMEDX CORPORATION·00813545023041·

P STR Pack 8 WELL

FDA UDI

SCIMEDX CORPORATION·00813545020620·

CMA RT HRT Test(L) 96

FDA UDI

SCIMEDX CORPORATION·00813545022884·

R. HRT/STR Pack 4 WELL

FDA UDI

SCIMEDX CORPORATION·00813545020545·

STR Muscle Test(L) 48

FDA UDI

SCIMEDX CORPORATION·00813545023027·

R. STR Pack 4 WELL

FDA UDI

SCIMEDX CORPORATION·00813545020637·

P HRT Pack 4 WELL

FDA UDI

SCIMEDX CORPORATION·00813545020507·

P HRT Pack 8 WELL

FDA UDI

SCIMEDX CORPORATION·00813545020514·

P STR Pack 4 WELL

FDA UDI

SCIMEDX CORPORATION·00813545020613·

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR

FDA Pre-Market Approval

PROTECTA CRT-D, PROTECTA XT CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR

ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LAPORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VP-1000; MED CAM 100; VP-3000A; MED CAM 300

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MGB DISPOSABLE RETRIEVAL BAG LAPBAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology