Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

The C100 Contactless Breathing Monitor

FDA 510(k)

FDA Class 2 ·Anesthesiology

OPTILITE C1 INACTIVATOR KIT

FDA 510(k)

FDA Class 2 ·Immunology

Unifine Pentips/ Unifine Pentips Plus

FDA 510(k)

FDA Class 2 ·General Hospital

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

FDA 510(k)

FDA Class 2 ·Immunology

MLT R694 RUBY LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

swiftPro™ System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUROSIGN AVALANCHE MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARDIOQ, MODEL 9051-7005

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology

VITALLINK3 MOBILE VITAL SIGNS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)

FDA 510(k)

FDA Class 2 ·Orthopedic

CAPTIA(R) CMV-G

FDA 510(k)

FDA Class 2 ·Microbiology

PICO Single Use Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

FDA 510(k)

FDA Class 2 ·Radiology

PERKINS HAND-HELD APPLANATION TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

MZ Skin LightMAX Supercharged LED Mask 2.0

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

FDA 510(k)

FDA Class 2 ·Immunology

E.P.T. CERTAINTY 1-STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology