Accessory, System, External Fixator, Containing Antimicrobial Agent

FDA classification

FDA Class 2 ·Accessory, System, External Fixator, Containing Antimicrobial Agent

NAJA Gastrointestinal Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NAJA™ Ligament Correction System

FDA 510(k)

FDA Class 2 ·Orthopedic

AMPLIFIER OTRONA, MODEL N3A-EMG

FDA 510(k)

FDA Class 2 ·Neurology

BEMITT, MODEL 0001

FDA 510(k)

FDA Class 2 ·Radiology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Brainance MD

FDA 510(k)

FDA Class 2 ·Radiology

Advantis Platform

FDA 510(k)

FDA Class 2 ·Radiology

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

FDA 510(k)

FDA Class 2 ·Immunology

CAMOUFLAGE CUFF SAVERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM

FDA 510(k)

FDA Class 2 ·Immunology

SCREWLINE

FDA 510(k)

FDA Class 2 ·Dental

PIEZOMED

FDA 510(k)

FDA Class 2 ·Dental

Ponto 5 Mini

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)

FDA 510(k)

FDA Class 2 ·Neurology

VPOD ITPR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Follicle Aspiration Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

FDA 510(k)

FDA Class 2 ·Hematology