Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

FDA 510(k)

FDA Class 2 ·General Hospital

COHORT AVB RETRACTOR SYSTEM

FDA 510(k)

FDA Class 1 ·Orthopedic

50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Visionbody

FDA 510(k)

FDA Class 2 ·Physical Medicine

BioProtect Balloon Implant™ System

FDA 510(k)

FDA Class 2 ·Radiology

Atrial Fibrillation History Feature

FDA 510(k)

FDA Class 2 ·Cardiovascular

SpaceOAR System

FDA 510(k)

FDA Class 2 ·Radiology

SpaceOAR System

FDA 510(k)

FDA Class 2 ·Radiology

Irregular Rhythm Notification Feature (IRNF)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Barrigel Injectable Gel

FDA 510(k)

FDA Class 2 ·Radiology

SpaceOAR Vue Hydrogel

FDA 510(k)

FDA Class 2 ·Radiology

IRNF App

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fitbit Irregular Rhythm Notifications

FDA 510(k)

FDA Class 2 ·Cardiovascular

SpaceOAR System

FDA 510(k)

FDA Class 2 ·Radiology

Irregular Rhythm Notification Feature

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Smart double sides wearable breast pump, Electric bilateral breast pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INTELEPACS, MODEL VERSION 3.X.X

FDA 510(k)

FDA Class 2 ·Radiology

35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery