BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

E.R.C.P. CANNULA PRODUCT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BioShield biopsy valve EUS - Linear

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALIEN RX MICRO CANNULA, MODEL 4530

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

WHILL Model M

FDA 510(k)

FDA Class 2 ·Physical Medicine

TEMPUSIC PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEMPUS PRO EXTENDED FEATURES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ceribell Pocket EEG Device

FDA 510(k)

FDA Class 2 ·Neurology

Arcad SmileStudio and Aligner System

FDA 510(k)

FDA Class 2 ·Dental

True 3D Viewer

FDA 510(k)

FDA Class 2 ·Radiology

TEMPUS IC PROFESSIONAL PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIDGET WORLD REPORTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M

FDA 510(k)

FDA Class 2 ·Orthopedic

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery