SBA 300 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Eversense 365 Continuous Glucose Monitoring (CGM) System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Eversense AP CGM System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANALYZER ABA-200

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ENIT ABA THYROXINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BICHROMATIC ANALYZER ABA-200

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NM-01/CPT neurometer (NM-01/CPT)

FDA 510(k)

FDA Class 2 ·Neurology

GTK Disposable Needle Guides

FDA 510(k)

FDA Class 2 ·Radiology

QUANTA LITE SS-A 52 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH

FDA 510(k)

FDA Class 1 ·Dental

GRAVITY PLUS CONTROLLER/COMPOUNDER

FDA 510(k)

FDA Class 2 ·General Hospital

AUTO-ALBUMIN REAG FOR ABBOTT ABA-100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed Stryker SERF AS Energy Probes

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

FDA 510(k)

FDA Class 2 ·Radiology

ABC FP ANALYZER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

FDA 510(k)

FDA Class 2 ·Orthopedic

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular