Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

FDA 510(k)

FDA Class 1 ·General Hospital

Muscle Stimulator Device (PZ-100)

FDA 510(k)

FDA Class 2 ·Physical Medicine

MedalOne Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Leltek Ultrasound Imaging System (Model: LU700 Series)

FDA 510(k)

FDA Class 2 ·Radiology

BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

Electronic Sphygmomanometer (Model: LT-P30)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging

FDA 510(k)

FDA Class 2 ·Radiology

Nitrile Examination Gloves

FDA 510(k)

FDA Class 1 ·General Hospital

Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)

FDA 510(k)

FDA Class 1 ·General Hospital

Vstrip H. pylori Antigen Rapid Test

FDA 510(k)

FDA Class 1 ·Microbiology

MARLE FINISHING SAS

FDA registration

MARLE FINISHING SAS·2 products·🇫🇷 France

ARTHREX, INC.

FDA registration

ARTHREX, INC.·2 products·🇺🇸 United States

Arthrex Singapore Pte Ltd.

FDA registration

Arthrex Singapore Pte Ltd.·2 products·🇸🇬 Singapore

Device Innovation Company Limited

FDA registration

Device Innovation Company Limited·2 products·🇹🇭 Thailand

PURACON GMBH

FDA registration

PURACON GMBH·2 products·🇩🇪 Germany