Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

LATEX PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

PATIENT EXAMINATION GLOVES (VINYL)

FDA 510(k)

FDA Class 1 ·General Hospital

FRENCH INTRA-AORTIC 9.5 BALLOON ON KON

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAT K IN VITRO DIAGNOSTIC TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACID PHOSPHATASE DIAG. KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BARBITURATE TEST SET #0550-050

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

lens, spectacle, non-custom (prescription)

FDA registration

J&Y SAFETY (M) SDN. BHD.·1 product·🇲🇾 Malaysia

Transparent dressing

FDA registration

GUANGDONG SOUTHVO MEDICAL TECHNOLOGY CO.,LTD·1 product·🇨🇳 China

Vitale STRONG Silver Calcium Alginate Dressing

FDA registration

CellEra, LLC·1 product·🇺🇸 United States

BioLink Patient Monitoring System

FDA registration

BioLink Systems, LLC·1 product·🇺🇸 United States

Vitale RTD Wound Dressing

FDA registration

CellEra, LLC·1 product·🇺🇸 United States

BPSS Affinity Wrist Fracture System

FDA registration

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

SkinPlus Disposable Skin Stapler

FDA registration

TAIWAN SURGICAL CORPORATION·1 product·🇹🇼 Taiwan

ReGen Laser

FDA registration

BIOPHOTONICA·1 product·🇺🇸 United States

Surgical Irrigation Pump

FDA registration

TAIWAN SURGICAL CORPORATION·1 product·🇹🇼 Taiwan

Glucertain Blood Glucose Test Strips

FDA registration

CellEra, LLC·2 products·🇺🇸 United States

InnoClip Disposable Clip Applier

FDA registration

TAIWAN SURGICAL CORPORATION·2 products·🇹🇼 Taiwan

OrthoNovis BPSS Cannulated Screws

FDA registration

ORTHONOVIS, INC.·3 products·🇺🇸 United States