ß-Glucocerebrosidase (Gba) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Glucocerebrosidase (Gba) Newborn Screening Test System

MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02

FDA 510(k)

FDA Class 2 ·Radiology

ENIT ABA THYROXINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Neurology

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

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

Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Archworx

FDA 510(k)

FDA Class 2 ·Dental

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Supreme and Response Electrophysiology Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed Synthes External Fixation Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular