RIVAL PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH

FDA 510(k)

FDA Class 2 ·Hematology

TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION

FDA 510(k)

FDA Class 2 ·Radiology

PATTON LAPAROSCOPIC CATHETER INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NUVIS DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SILICONE FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COOK INSEMINATION CUP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACU-TEST IN-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Anti-Jkb monoclonal, human IgM clone: MS-8

Device

EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·On the market

ossFX Moldable

FDA UDI

Biogennix, LLC·00812593021627·ossFX Moldable 1.5cc

ossFX

FDA UDI

Biogennix, LLC·00812593021603·ossFX 6cc

ossFX Moldable

FDA UDI

Biogennix, LLC·00812593021658·ossFX Moldable 12cc

ossFX Strip

FDA UDI

Biogennix, LLC·00812593021672·ossFX Strip Large

ossFX

FDA UDI

Biogennix, LLC·00812593021610·ossFX 12cc

ossFX

FDA UDI

Biogennix, LLC·00812593021597·ossFX 3cc

ossFX Moldable

FDA UDI

Biogennix, LLC·00812593021634·ossFX Moldable 3cc

ossFX

FDA UDI

Biogennix, LLC·00812593021580·ossFX Fusion Kit

ossFX Strip

FDA UDI

Biogennix, LLC·00812593021665·ossFX Strip Medium