STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

OPUS FERRITIN TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

UTERMOHLEN CRYO PROFESSIONAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

AGEE EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BAND-AGE ICE-BANDAGE

FDA 510(k)

FDA Class 2 ·Physical Medicine

MS-39

FDA 510(k)

FDA Class 2 ·Ophthalmic

LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALEX TA2 ERASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Q-CLEAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIGHT AGE EPICARE ALEXANDRITE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HIPUSH HANDHELD MASSAGER

FDA 510(k)

FDA Class 1 ·Physical Medicine

MULTIPLE ACCESSORY TO GAMMA CAMERAS

FDA 510(k)

FDA Class 1 ·Radiology

EPICARE YAG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EPICARE-DUO LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIGHT AGE Q-CLEAR LASER, MODEL 701-1101

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery