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

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

UNIGOLD GIARDIA

FDA 510(k)

FDA Class 2 ·Microbiology

PROSPECT(TM/CRYPTOSPORIDIUM

FDA 510(k)

FDA Class 2 ·Microbiology

TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

LMD CRYPTOSPORIDIUM ANTIGEN DETECTION

FDA 510(k)

FDA Class 2 ·Microbiology

CRYPTO-CEL IF TEST

FDA 510(k)

FDA Class 2 ·Microbiology

GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK

FDA 510(k)

FDA Class 2 ·Microbiology

PROSPECT(TM) GIARDIA RAPID ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

PREMIER CRYPTOSPORIDIUM

FDA 510(k)

FDA Class 2 ·Microbiology

MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA

FDA 510(k)

FDA Class 2 ·Microbiology

GIARDIA CELISA

FDA 510(k)

FDA Class 2 ·Microbiology

PROSPECT GIARDIA CONTROLS

FDA 510(k)

FDA Class 2 ·Microbiology

CRYPTOSPORIDIUM II

FDA 510(k)

FDA Class 2 ·Microbiology