JPS JuniOrtho Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter, Curled, Double Cuff (Ref M7200)

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3-PCS MONOFOCAL LENS

NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS

FDA 510(k)

FDA Class 2 ·Orthopedic

SOL-GUARD Safety Pull Button Collection Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alivio Ventricular Catheter and Flusher System (Alivio System)

FDA 510(k)

FDA Class 2 ·Neurology

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Inspiris Resilia Aortic Valve

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·INSPIRIS RESILIA Aortic Valve, Model 11500A

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RESONATE™ HF, RESONATE™ EL, MOMENTUM™ EL, VIGILIANT™ EL, PERCIVA™ HF, PERCIVA™

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic +, Atlas/II/+, Convert/+, Photon

Bencox M Stem Lateralized & Bencox Mirabo Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug

FDA 510(k)

FDA Class 2 ·Orthopedic

Bencox Mirabo Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SHADOW-CATHS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology