Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON DUET DUAL PACK

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

FDA classification

FDA Class 2 ·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN LV & CS & OTW & ATTAIN BIPOLAR OTW

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 & LV-1 HEART FAILURE LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241020584·DyeVert Plus EZ Contrast Reduction System

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241020720·DyeVert Plus EZ Contrast Reduction System

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241021055·DyeVert Plus EZ Contrast Reduction System

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241020645·DyeVert Plus EZ Contrast Reduction System

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241021048·DyeVert Plus EZ Contrast Reduction System.

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK LEAD MODELS IS-1 4535/4536/4537/4538 CORONARY VENOUS STEROID-ELUTING SINGLE-ELECTRODE PACE/SENSE LEAD

Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

FDA classification

FDA Class 2 ·Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III CRT-P/ATTAIN OTW LEAD/BIPOLAR OTW/LV LEADS