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

FDA 510(k)

FDA Class 2 ·General Hospital

Biological Sterilization Indicator With Indirect Growth Detection

FDA classification

FDA Class 2 ·Biological Sterilization Indicator With Indirect Growth Detection

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