Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) ASSAY

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

Arc Endocuff Glide AEG110 & AEG120

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

OLYMPUS MOBILE CHAIR/COUCH

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CENTRAFIX EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PICO SMOKERLYZER, MODEL EC-50

FDA 510(k)

FDA Class 2 ·Anesthesiology

EmbedMed

FDA 510(k)

FDA Class 2 ·Dental

Wearable breast pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HYDROCOLLOID WOUND DRESSINGS

FDA 510(k)

FDA Unclassified ·Unknown

DISPOS. I/A & IRRIGATION HANDPIECES

FDA 510(k)

FDA Class 2 ·Ophthalmic

MARQUETTE 1200 DEFIBRILLATION PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

'EXMOOR' SHAH & MACKAY NASAL SPLINTS

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

SST SALIVA SUPPORTING TABLETS

FDA 510(k)

FDA Class 1 ·Hematology

MODIFICATION OF MLT R694 RUBY LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BAWMED RESCUE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

Habib EUS RFA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ONQ RTS

FDA 510(k)

FDA Class 2 ·Radiology