Belun Sleep System BLS-100

FDA 510(k)

FDA Class 2 ·Anesthesiology

Caretaker Remote Display App and Caretaker Software Library

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE HEATING TUBING SET #7642HSES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MULTI HI-FLO PNEU, WISAP #7080

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

POWER-DRIVE, WISAP MODEL #7688PD/7688PD1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FLOW-THERME, WISAP #7642

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HI-FLO THERME PNEU 45, WISAP #7083, 7083V

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

e-SDF

FDA 510(k)

FDA Class 2 ·Dental

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

InPen System App (MMT-8060 (iOS), MMT-8061 (Android))

FDA 510(k)

FDA Class 2 ·Anesthesiology

Rooti Rx ECG Event Recorder, Rooti Link APP Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRYPTOSPORIDIUM ANTIGEN DETECTION

FDA 510(k)

FDA Class 2 ·Microbiology

TRI-COMBO PARASITE SCREEN

FDA 510(k)

FDA Class 2 ·Microbiology

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

FDA 510(k)

FDA Class 2 ·Microbiology