NEEDLES, DESIGN CHANGE, IV CATHETERS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

PARACENTESIS CATHETER DEVICE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MANAN EPIDURAL NEEDLE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

TURKEL PNEUMOTHORAX KIT

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ADAIR/VERESS NEEDLE INTRODUCER SET

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

Valved Safety Centesis Catheter

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

Monarch Platform, Urology

FDA registration

Auris Health, Inc·5 products·🇺🇸 United States

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·5 products·🇺🇸 United States

Monarch Platform, Urology

FDA registration

Auris Health, Inc.·5 products·🇺🇸 United States

Needle, Catheter

FDA classification

FDA Class 1 ·Needle, Catheter

Gas Control Equipment Limited

Manufacturer

1 Importer

BCB Medical AB

Manufacturer

🇸🇪 Sweden·1 Basic UDI-DI·1 Device

BCB Medical Oy

Manufacturer

🇫🇮 Finland·1 Basic UDI-DI·81 Devices

ACB VALE s.r.o.

Manufacturer

🇨🇿 Czechia

Model: G1B and G1B Plus

FDA registration

GENERAL MEDITECH, INC.·1 product·🇨🇳 China

Mediconnect

FDA registration

GCE, s.r.o.·1 product·🇨🇿 Czechia

MediFlowTec

FDA registration

GCE, s.r.o.·1 product·🇨🇿 Czechia

Medievac+

FDA registration

GCE, s.r.o.·1 product·🇨🇿 Czechia

MediVital E

FDA registration

GCE, s.r.o.·1 product·🇨🇿 Czechia

GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600

FDA registration

GCE, s.r.o.·1 product·🇨🇿 Czechia