ON-Q* Pump with Bolus

FDA 510(k)

FDA Class 2 ·General Hospital

Signia Stapler (with new software)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POWER TRAINER WITH NEUROMUSCULAR STIMULATION

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETER WITH 3.5 MM BALLOON

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC DEVICE WITH INSTRUMENTATION (20MM)

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

FDA 510(k)

FDA Class 2 ·Cardiovascular

Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

FDA 510(k)

FDA Class 2 ·General Hospital

ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE

FDA 510(k)

FDA Class 2 ·Anesthesiology

VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations

FDA 510(k)

FDA Class 2 ·Orthopedic

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM

FDA 510(k)

FDA Class 2 ·Orthopedic

QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular