PROTEUS PATCH INCLUDING INGESTIBLE SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

Otsuka Digital Feedback Device

FDA 510(k)

FDA Class 2 ·General Hospital

Proteus Digital Health Feedback Device

FDA 510(k)

FDA Class 2 ·General Hospital

Otsuka Digital Feedback Device-RW

FDA 510(k)

FDA Class 2 ·General Hospital

PROTEUS INGESTION CONFINMATION SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)

FDA 510(k)

FDA Class 2 ·General Hospital

PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)

FDA 510(k)

FDA Class 2 ·General Hospital

ID-Cap System

FDA 510(k)

FDA Class 2 ·General Hospital

Ingestible Event Marker

FDA classification

FDA Class 2 ·Ingestible Event Marker

OSW Aligner System

FDA 510(k)

FDA Class 2 ·Dental

Laser Speckle Imaging System (RFLSI CZW)

FDA 510(k)

FDA Class 2 ·Cardiovascular

INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022

FDA 510(k)

FDA Class 2 ·General Hospital

DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology