AB Medical, Inc.

Manufacturer

🇰🇷 South Korea·32 Basic UDI-DIs·32 Devices

DxTx Medical, Inc.

Manufacturer

🇺🇸 United States

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT STRIP BONE GRAFT MATRIX

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM (VCS)

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT

FDA 510(k)

FDA Class 2 ·General Hospital

Advance Medical Designs, Inc. Sterile Ultrasound Gel

FDA 510(k)

FDA Class 2 ·Radiology

BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Remington Medical, Inc. Automatic Cutting Needle (NAC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.

FDA 510(k)

FDA Class 2 ·Ophthalmic

GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental