Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Jimushi Sterile Urethral Catheter for single use

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AmCAD-UT

FDA 510(k)

FDA Class 2 ·Radiology

Picosecond Nd:YAG Laser Systems (BL-C10)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ERI Handheld Dental X-ray System (Model AG100)

FDA 510(k)

FDA Class 2 ·Dental

Multi-function Platform Systems (BL-M10)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Denture Base

FDA 510(k)

FDA Class 2 ·Dental

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

FDA 510(k)

FDA Class 2 ·Cardiovascular

oCare Wrist Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Light Therapy System (M500, L6)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EpiFaith CV

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

PVC Hydrophilic Urethral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

InferRead Lung CT.AI

FDA 510(k)

FDA Class 2 ·Radiology