EEA Circular Stapler with Tri-Staple Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Endoscopy Irrigation Tubing

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Glass Ceramic

FDA 510(k)

FDA Class 2 ·Dental

Dental Cone-beam Computed Tomography

FDA 510(k)

FDA Class 2 ·Radiology

Wireless TENS & EMS (Model SM9110,SM9113,SM9116)

FDA 510(k)

FDA Class 2 ·Neurology

GT5 conductive & abrasive gel

FDA 510(k)

FDA Class 2 ·Neurology

Reusable SpO2 Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Disposable Temperature Probe

FDA 510(k)

FDA Class 2 ·General Hospital

maxFit II Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

FDA classification

FDA Class 2 ·Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

Reprocessed Catheter Introducer

FDA classification

FDA Class 2 ·Reprocessed Catheter Introducer

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

External Cleaning Solution

FDA classification

FDA Class 2 ·External Cleaning Solution

Digital Radiography System (ManntiX B, ManntiX K)

FDA 510(k)

FDA Class 2 ·Radiology

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Wearable breast pump (model S12A)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology