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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE

ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis

FDA 510(k)

FDA Unclassified ·Unknown

HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY

FDA 510(k)

FDA Unclassified ·Unknown

Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis

FDA 510(k)

FDA Unclassified ·Unknown

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, APPLICATION SOFTWARE, DEFRILLATION SUPPORT DEVICE (DISD) END CAP, EPICCARDIAL PATCH LEAD SIZILING SLEEVE UPS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, CABLE, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, PATIENT MAGNET, UPSIZING SLEEVE

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

Bag, Ice

FDA classification

FDA Class 1 ·Bag, Ice

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ACCESSORY (UPSIZING SLEEVE)

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) (with and without InhibiZone)

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 SERIES INFATABLE PENILE PROSTHESIS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESIS

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT ARCHITECT TOTAL PSA

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMBICOR INFLATABLE PENILE PROSTHESIS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment