GAP ENDO-EXO MEDULLARY SYSTEM

FDA UDI

Pega Medical Inc·07540194000965·Nail Ø6.4mm X 300mm

GAP ENDO-EXO MEDULLARY SYSTEM

FDA UDI

Pega Medical Inc·07540194004529·Cortical Peg Ø2.5mm X 24mm

GAP ENDO-EXO MEDULLARY SYSTEM

FDA UDI

Pega Medical Inc·07540194001603·Cortical Screw Ø4.0mm X 80mm

GAP ENDO-EXO MEDULLARY SYSTEM

FDA UDI

Pega Medical Inc·07540194000910·Nail Ø6.4mm X 200mm

GAP ENDO-EXO MEDULLARY SYSTEM

FDA UDI

Pega Medical Inc·07540194001573·Cortical Screw Ø4.0mm X 65mm

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar and Quadripolar CRT-P, Serena Bipolar and Quadripolar CRT-P, Solar Bipolar and Quadripolar CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1, MRI, S DR, S VR, XT DR, and XT VR ICD, Mirro MRI DR and MRI VR ICD, Primo MRI DR and MRI VR ICD, Protect

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI and MRI Quad CRT-D, Brava CRT-D and Quad CRT-D, Claria MRI and MRI Quad CRT-D, Compia MRI and MRI Quad CRT-D,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR, DR MRI, and SR MRI IPG, Astra S DR MRI, S SR MRI, XT DR MRI, and XT SR MRI IPG, Azure S DR MRI, S SR MRI, XT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Urinary Control System

FDA Pre-Market Approval

PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDS

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEMETECH SILK NONABSORBABLE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HANDLES, LIGHT, SURGICAL, STEOILE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SOFSILK SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNISILK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery