EndoRotor

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

SurgiLance® Safety Lancet

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TipTraQ (TTQ001)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

Quantum Mitohormesis (QMT) (M2101)

FDA 510(k)

FDA Class 2 ·Physical Medicine

AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Respiree Cardio-Respiratory Monitor

FDA 510(k)

FDA Class 2 ·Anesthesiology

AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

BABYLANCE HEEL INCISION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REKA E100

FDA 510(k)

FDA Class 2 ·Cardiovascular

KIDNEY PERFUSION MACHINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

ProSeal™ Injection Site Extended Male Luer Lock (422140)

FDA 510(k)

FDA Class 2 ·General Hospital

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

FDA 510(k)

FDA Class 2 ·General Hospital