Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE DF4 LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRT IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

FDA Pre-Market Approval

BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·DIASONICS MT/S (MAGNETIC TOMOGRAPHY/SUPERCONDUCTIN

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN (MODEL MMT-522/MMT-522K/MMT-722/MMT-722K/MMT-523/MMT-523K/MMT-723/MMT-723K)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM.

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·Capsular Tension Ring (CTR) and RingJect

Test Reagents, Neisseria Gonorrhoeae Biochemical

FDA Pre-Market Approval

FDA Class 1 ·GONODECTEN

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·GEOPEN SUSCEPTIBILITY POWDER

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·BACITRACIN DIAGNOSTIC SUSCEPTIBILITY POWDER

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·POTASSIUM PENICILLIN G DIAG SYS POWDER

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN