Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP PROCESSORS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne, and Restylane Kysse

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·Alair Bronchial Thermoplasty System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS); PROGEL Spare Tips accessory; PROGEL 6 Extended Tips accessory; PROGEL 11 Extende

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLUORON OCULAR ENDOTAMPONADE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ;

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THIN PREP PROCESSORS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-PMMA PCL'S

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·Model 203 Life Pulse High Frequency Ventilator

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL LEAK SEALANT

Device, Cystometric, Air

FDA classification

FDA Class 3 ·Device, Cystometric, Air