Sunscreen mask

FDA registration

WENZHOU ZUOYOU MEDICAL TECHNOLOYG CO.,LTD.·1 product·🇨🇳 China

Douche Apparatus

FDA registration

WENZHOU ZUOYOU MEDICAL TECHNOLOYG CO.,LTD.·1 product·🇨🇳 China

bandage, Band-aid

FDA registration

WENZHOU ZUOYOU MEDICAL TECHNOLOYG CO.,LTD.·1 product·🇨🇳 China

Kidney Belt

FDA registration

WENZHOU ZUOYOU MEDICAL TECHNOLOYG CO.,LTD.·1 product·🇨🇳 China

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II/PRIME HTD CATHETER

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant System

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

FDA 510(k)

FDA Class 1 ·General Hospital

Roche Digital Pathology Dx (VENTANA DP 200)

FDA 510(k)

FDA Class 2 ·Pathology

Roche Digital Pathology Dx

FDA 510(k)

FDA Class 2 ·Pathology

Danny Ties Tracheostomy Ties

FDA registration

Qingdao Leckie Foam Products Co. Ltd.·1 product·🇨🇳 China

Urethrotech UCD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEPOTONE

FDA 510(k)

FDA Class 2 ·General Hospital

DEPOTONE

FDA 510(k)

FDA Class 2 ·General Hospital

FABRIS LAN SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.

Manufacturer

45 Basic UDI-DIs·45 Devices·HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD CARDIAC ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD CARDIAC ABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER