SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

Elecsys Anti-SARS-CoV-2

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

FDA 510(k)

FDA Class 2 ·Microbiology

14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300

FDA 510(k)

FDA Class 2 ·General Hospital

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HepaShield Bacterial Viral Breathing System Filter

FDA 510(k)

FDA Class 2 ·Anesthesiology

ThermoShield HME Filter

FDA 510(k)

FDA Class 2 ·Anesthesiology

SINGLE USE MANOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20

FDA 510(k)

FDA Class 2 ·Anesthesiology

SmoothSkin Pure Switch (SSC1)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SmoothSkin Pure Adapt (SSG3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SmoothSkin Pure Unplugged (SSB3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery