BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA

FDA 510(k)

FDA Class 2 ·Microbiology

BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

STORS SCLERAL SPONGE II (LINCOFF DESIGN)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Ameda GLO Wearable Breast Pump (Model W8S)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Immunology

LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ANCHORSURE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPSY MEDIUM, MODEL REF 1062

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

XCEL 455 SLIT LAMP

FDA 510(k)

FDA Class 2 ·Ophthalmic

RM Electrode (RMH 23-01)

FDA 510(k)

FDA Class 2 ·Ophthalmic

PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

FDA 510(k)

FDA Class 2 ·Microbiology

TROJAN PASSION BERRY GEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY

FDA 510(k)

FDA Class 2 ·Ophthalmic

SYSTEM U3

FDA 510(k)

FDA Class 2 ·Microbiology