HAEMODIALYSIS CONCENTRATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BDH FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINE ALIGN

FDA 510(k)

FDA Class 2 ·Orthopedic

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)

FDA 510(k)

FDA Class 2 ·Physical Medicine

BDH UNIVERSAL HIP SYSTEM SURGEON

FDA 510(k)

FDA Class 2 ·Orthopedic

BDH BIPOLAR FEMORAL COMPONENT A3

FDA 510(k)

FDA Class 2 ·Orthopedic

BDH UNIPOLAR FEMORAL COMPONENT A2

FDA 510(k)

FDA Class 2 ·Orthopedic

CONDOM TAKASO RUBBER PRODUCTS SDN/BDH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PASTURE, MODELS: F550, A520

FDA 510(k)

FDA Class 2 ·General Hospital

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

SURGICAL FACE MASK (Ear Loops and Tie-on)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HOTWIRE™ RF Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE

FDA 510(k)

FDA Class 2 ·Ophthalmic

ACTIPROTECT UC N95 RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SYNAPSE 3D BRAIN PERFUSION

FDA 510(k)

FDA Class 2 ·Radiology

ASPIRE Cristalle

FDA 510(k)

FDA Class 2 ·Radiology

SYNAPSE 3D TENSOR ANALYSIS

FDA 510(k)

FDA Class 2 ·Radiology

ASPIRE Bellus II

FDA 510(k)

FDA Class 2 ·Radiology

SYNAPSE 3D COLON ANALYSIS

FDA 510(k)

FDA Class 2 ·Radiology