Pulsaderm Acne Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Revolution™ Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Z1 Cemented Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL BILIRUBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Nisus Touch Negative Pressure Wound Therapy Pump

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEUCADIA AUTOLOK™ Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135

FDA 510(k)

FDA Class 2 ·General Hospital

IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments

FDA 510(k)

FDA Class 2 ·Dental

ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ICONACY(TM) I-Hip (TM)

FDA 510(k)

FDA Class 2 ·Orthopedic

TIBURON SURGICAL DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VEGA Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

SleepImage System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Advanced Research Medical Trident SI Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

Esophageal Cooling Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

KY Grosz Jelly

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology