PK AIM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PK J-HOOK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DOLPHIN 3 FLUID MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYRUS ACMI BIOCOAG PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PK AIM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GYRUS AMCI PK BUTTON ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PK NEEDLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POWERSEAL Sealer and Divider

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP & CAPSURE Z

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX

GYRUS ACMI, INC

FDA UDI

Gyrus Acmi, Inc.·00821925025509·MICRON II ALL TITANIUM OFF-CENTERED TORP 8.0MM...

GYRUS ACMI, INC

FDA UDI

Gyrus Acmi, Inc.·00821925015852·HOUSE TYPE LANCET KNIFE