AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A

FDA 510(k)

FDA Class 2 ·Cardiovascular

DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC

FDA 510(k)

FDA Class 2 ·Dental

SoundBite® Crossing System XS Peripheral

FDA 510(k)

FDA Class 2 ·Cardiovascular

SoundBite Console, SoundBite Active Wire 18

FDA 510(k)

FDA Class 2 ·Cardiovascular

STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD Centro Vena Acute Central Line (7 French Dual Lumen)

FDA 510(k)

FDA Class 2 ·General Hospital

BD Acute Central Line

FDA 510(k)

FDA Class 2 ·General Hospital

AcroDTI Visualizer

FDA 510(k)

FDA Class 2 ·Radiology

EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM

FDA 510(k)

FDA Class 2 ·Physical Medicine

MAGBODY DT-600

FDA 510(k)

FDA Class 2 ·Neurology

MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER