VitriGuard

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TITAN

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

B&R DEVICE

FDA 510(k)

FDA Class 1 ·Dental

Elos Accurate Hybrid Base

FDA 510(k)

FDA Class 2 ·Dental

SAFE MINI

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS

FDA 510(k)

FDA Class 2 ·General Hospital

Elos Accurate Customized Abutment

FDA 510(k)

FDA Class 2 ·Dental

TINNITUS SOUND GENERATOR MODULE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEURO URODYNAMIC SUITE, MODEL 9032E0101

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Ambu USR, Ambu M

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WSA Self-Fitting Hearing Aid Gen 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARDIOCAM MODEL 9CSY0799

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TeesuVac Breast Biopsy Device Mark 1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRASOUND SCANNER FLEX FOCUS 1202

FDA 510(k)

FDA Class 2 ·Radiology

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)

FDA 510(k)

FDA Class 2 ·Hematology