AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

FDA 510(k)

FDA Class 2 ·Cardiovascular

LASER SYSTEM YELLOWSTAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HOLY DRAGON ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

BOND-IT DUAL CURE ACTIVATOR

FDA 510(k)

FDA Class 2 ·Dental

CORDIS STEERABLE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HealthBeacon HB2 Sharps Bin

FDA 510(k)

FDA Class 2 ·General Hospital

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

FDA 510(k)

FDA Class 2 ·Cardiovascular

Straumann BLX Ø3.5 mm Implants

FDA 510(k)

FDA Class 2 ·Dental

NOVA CO-OXIMETER ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

TANDA MAX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA SKINCARE SYSTEM, MODEL: PTSCS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA RESTORE, MODEL PTSCS

FDA 510(k)

FDA Class 2 ·Physical Medicine

EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)

FDA 510(k)

FDA Class 2 ·Neurology

MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED

FDA 510(k)

FDA Class 2 ·Cardiovascular