GENESIS TOUCH SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEALTHANYWHERE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BioStamp nPoint

FDA 510(k)

FDA Class 2 ·Cardiovascular

LifeSignals Multi-Parameter Remote Monitoring Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

LifeSignals ECG Remote Monitoring Patch Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMBULATORY X-12 TELEMETRY MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING

FDA 510(k)

FDA Class 2 ·Dental

Transmitters And Receivers, Physiological Signal, Radiofrequency

FDA classification

FDA Class 2 ·Transmitters And Receivers, Physiological Signal, Radiofrequency

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

ARGES IMAGING CONTRAST SPRAY

FDA 510(k)

FDA Class 2 ·Dental

CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Allied Biocompat Abutment for Nobel Replace Interface

FDA 510(k)

FDA Class 2 ·Dental

IDECAP DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASTar BC G- Kit and ASTar Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

FDA 510(k)

FDA Class 2 ·Radiology

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery