GENEX BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Orthopedic

Axial3D Cloud Segmentation Service

FDA 510(k)

FDA Class 2 ·Radiology

CLEARVIEW HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HAEMOCELL SYSTEM 350 OR S350

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LYMA Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rugged Oxygen Generator (ROG) (RO01-00001)

FDA 510(k)

FDA Class 2 ·Anesthesiology

THE KEYMED FIBERSCOPE STERILIZATION CASE

FDA 510(k)

FDA Class 2 ·General Hospital

AUTOSTAT ANTI-THYROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SECURE-LOOP

FDA 510(k)

FDA Class 2 ·Orthopedic

Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE

FDA 510(k)

FDA Class 2 ·Dental

DIASUS

FDA 510(k)

FDA Class 2 ·Radiology

PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

InnoSpire Go

FDA 510(k)

FDA Class 2 ·Anesthesiology

BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology