Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Xpert® Xpress CoV-2 plus

FDA 510(k)

FDA Class 2 ·Microbiology

EConsole1

FDA 510(k)

FDA Class 2 ·Radiology

XERO-alpha

FDA 510(k)

FDA Class 2 ·Dental

Ultrasonic scaler

FDA 510(k)

FDA Class 2 ·Dental

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP

FDA 510(k)

FDA Class 2 ·Radiology

EXPD 4343P, EXPD 3643P

FDA 510(k)

FDA Class 2 ·Radiology

EXTRON 5; EXTRON 7

FDA 510(k)

FDA Class 2 ·Radiology

RMF-2000

FDA 510(k)

FDA Class 2 ·Radiology

EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG

FDA 510(k)

FDA Class 2 ·Radiology

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

FDA 510(k)

FDA Class 2 ·Radiology

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

FDA 510(k)

FDA Class 2 ·Radiology

ENHANCE CLITORAL STIMULATION AID

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Modified Novy Cornual Cannulation Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OVAMED INTRAUTERINE ACCESS CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EROS-CLITORAL THERAPY DEVICE (CTD)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology