Ambler Surgical

FDA UDI

AMBLER SURGICAL CORP.·00190660137045·Horizontal self-retaining retractor, 12 1/4", h...

Avalign

FDA UDI

Avalign Technologies, Inc.·00190776076580·Distractor Multilever Distractor, Short Bar

Ambler Surgical

FDA UDI

AMBLER SURGICAL CORP.·00190660133689·Contour self-retaining scalp retractor, 5 1/2",...

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES

I3 BioMedical Inc.

Manufacturer

🇨🇦 Canada

Addition Technology Inc

Manufacturer

🇺🇸 United States·1 Importer

DARCO International, Inc.

Manufacturer

🇺🇸 United States·1 Importer

APT Medical Inc.

Manufacturer

🇨🇳 China·1 Basic UDI-DI·17 Devices·SGS Belgium NV

Unisensor USA, Inc.

Manufacturer

🇺🇸 United States

Epimed International, Inc.

Manufacturer

🇺🇸 United States·2 Importers

Harpoon Medical, Inc.

Manufacturer

🇺🇸 United States

CEMAR ELECTRO INC

Manufacturer

🇨🇦 Canada·1 Importer

Incrediwear Holdings, Inc.

Manufacturer

🇺🇸 United States·4 Basic UDI-DIs·210 Devices·1 Importer

Aspire Bariatrics Inc.

Manufacturer

🇺🇸 United States

Insera Therapeutics, Inc.

Manufacturer

🇺🇸 United States

iLumi Sciences Inc.

Manufacturer

🇺🇸 United States

Ilion Medical Inc

Manufacturer

🇺🇸 United States

SELVAS Healthcare, Inc.

Manufacturer

🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·1 Importer·TÜV Rheinland LGA Products GmbH

Ondine Biomedical Inc.

Manufacturer

🇨🇦 Canada

Surgical Concepts, Inc.

Manufacturer

🇺🇸 United States