System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA CATHETERS

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY

RESUSCITATOR MODELS 10400/10500/10600/10700/10800

FDA 510(k)

FDA Class 2 ·Anesthesiology

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

Synergy Platform, Synergy, Infinity, VersaHD

FDA 510(k)

FDA Class 2 ·Radiology

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTEGRITY MODEL 1014284

FDA 510(k)

FDA Class 2 ·Radiology

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts

FDA 510(k)

FDA Class 2 ·Cardiovascular

Patient Status Engine

FDA 510(k)

FDA Class 2 ·Cardiovascular

XVI R5.0

FDA 510(k)

FDA Class 2 ·Radiology

VASCUTEK CANNULA GRAFT, MODEL CGS2008S

FDA 510(k)

FDA Class 2 ·Cardiovascular

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD

FDA 510(k)

FDA Class 2 ·Radiology

AGILITY

FDA 510(k)

FDA Class 2 ·Radiology

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

XVI R4.5

FDA 510(k)

FDA Class 2 ·Radiology

Elekta Unity

FDA 510(k)

FDA Class 2 ·Radiology

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

FDA 510(k)

FDA Class 2 ·Radiology

APEX

FDA 510(k)

FDA Class 2 ·Radiology