Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FREQUENCY MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS)

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN ICL (IMPLANTABLE COLLAMER LENS)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODEL C STAR

Prosthesis, Testicle

FDA classification

FDA Class 3 ·Prosthesis, Testicle

INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

P.F.C. APICAL PLUG

FDA 510(k)

FDA Class 3 ·Orthopedic

MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 483-02 PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-09 ADAPTAID ADAPTER SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

POLYFLEX IMPLANTABLE PACING LEAD-476-07

FDA 510(k)

FDA Class 3 ·Cardiovascular