System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU

ALLIVE

FDA UDI

Nu Eyne Co., Ltd.·08800051500021·

ELEXIR

FDA UDI

Nu Eyne Co., Ltd.·08800051500199·

Alice 6 Headbox LDE

FDA registration

CEVA LOGISTICS LIMITED·2 products·🇬🇧 United Kingdom

12/24V Battery Cable w/terminals or adapter

FDA registration

CEVA LOGISTICS LIMITED·2 products·🇬🇧 United Kingdom

ComfortFull FFM - RSZ

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom

SUR-FIT NATURA & SUR-FIT Autolock D

FDA registration

ConvaTec Limited, GDC Building·1 product·🇬🇧 United Kingdom

Performax, FitLife EE Total Face Mask

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom

Drain, Tee (water trap)

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom

CEVA LOGISTICS LIMITED

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom

Vitalsense

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom

Asthma Check;

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom

AQUACEL Ag Burn

FDA registration

ConvaTec Limited, GDC Building·1 product·🇬🇧 United Kingdom

GentleCath Glide

FDA registration

ConvaTec Limited, GDC Building·2 products·🇬🇧 United Kingdom

Cure Catheter Hydrophilic Coated

FDA registration

ConvaTec Limited, GDC Building·1 product·🇬🇧 United Kingdom

Airways (Disposable Manual Pulmonary Res.)

FDA registration

ConvaTec Limited, GDC Building·1 product·🇬🇧 United Kingdom

NATURA SUR-FIT Closed-End Pouch

FDA registration

ConvaTec Limited, GDC Building·1 product·🇬🇧 United Kingdom

CEVA LOGISTICS LIMITED

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom

PLV-102 & 102b

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom

WhisperFlow Procedure Packs

FDA registration

CEVA LOGISTICS LIMITED·1 product·🇬🇧 United Kingdom