228 results · 24ms · Sources: EU EUDAMED, US FDA

Xpert Xpress Strep A

FDA 510(k)
FDA Class 2 ·Microbiology

Accula Strep A Test

FDA 510(k)
FDA Class 2 ·Microbiology

Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack

FDA 510(k)
FDA Class 2 ·Microbiology

AMPLIVUE GAS ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

FDA 510(k)
FDA Class 2 ·Microbiology

ALERE I STREP A

FDA 510(k)
FDA Class 2 ·Microbiology

LYRA DIRECT STREP ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

GenePOC Strep A

FDA 510(k)
FDA Class 2 ·Microbiology

neuro inspire

FDA 510(k)
FDA Class 2 ·Neurology

DESENTECH PLUME-EVAC SMOKE EVACUATION SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval
FDA Class 2 ·DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)

BLOOD PRESSURE METER MODEL NO. BPM888

FDA 510(k)
FDA Class 2 ·Cardiovascular

MAXFORCE TTS SINGLE-USE BALLOON DILATOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Reprocessed Compression Garments

FDA 510(k)
FDA Class 2 ·Cardiovascular

TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

FDA 510(k)
FDA Class 2 ·Radiology