23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

MUTYH-Associated Polyposis (MAP)

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

FDA 510(k)

FDA Class 2 ·Medical Genetics

Cancer Predisposition Risk Assessment System

FDA classification

FDA Class 2 ·Cancer Predisposition Risk Assessment System

TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE

FDA 510(k)

FDA Class 2 ·General Hospital

Stylus

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMARTSPOT 2000

FDA 510(k)

FDA Class 2 ·Radiology

BIOCERAM DENTAL IMPLANT, SERIES II

FDA 510(k)

FDA Class 2 ·Dental

SMART RAD

FDA 510(k)

FDA Class 2 ·Radiology

Sensilight Pro / Pistol IPL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BEHIND EAR GENTLE TOUCH THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE

FDA 510(k)

FDA Class 2 ·General Hospital

J & P Click Attachments

FDA 510(k)

FDA Class 2 ·Dental

BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS

FDA 510(k)

FDA Class 2 ·General Hospital

NO TOUCH+FOREHEAD NTF 3000 THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER