HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

FDA classification

FDA Class 2 ·Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

APE

FDA registration

SAFEGUARD US OPERATING, LLC·1 product·🇺🇸 United States

PLASTI - APE - S.P.A.

Manufacturer

🇮🇹 Italy

EA ES

FDA registration

WENZHOU OUHAI JINGTAI GLASSES CO., LTD.·1 product·🇨🇳 China

UNION PLASTIC DIVISION APE

Manufacturer

🇫🇷 France

FAE Famed Łódź S.A.

Manufacturer

🇵🇱 Poland·7 Basic UDI-DIs·38 Devices

Manual Medical Beds: APE-15, APE-14, APE-13, AA-6, FS-01

FDA registration

SHANDONG DEMAN MEDICAL EQUIPMENT GROUP CO., LTD·1 product·🇨🇳 China

A BATHING APE

FDA registration

VISION POSSIBLE LIMITED·1 product·🇭🇰 Hong Kong

A BATHING APE

FDA registration

VISION POSSIBLE LIMITED·1 product·🇭🇰 Hong Kong

Obtura Spartan

FDA UDI

OBTURA SPARTAN ENDODONTICS·00816168020749·EMS Threaded Tip BUC-2AE

ELITE OPTICAL SUNGLASSES

FDA registration

Dongguan Huijun Eyeglasses Products Company Limited·1 product·🇨🇳 China

ELITE OPTICAL FRAMES

FDA registration

Dongguan Huijun Eyeglasses Products Company Limited·1 product·🇨🇳 China

DAE MYUNG CHEMICAL CO., LTD. (VIETNAM)

Manufacturer

🇻🇳 Vietnam·TÜV Rheinland LGA Products GmbH

COMPLEMENT ACTIVATION EIA (CAE) KIT

FDA registration

DIASORIN INC.·1 product·🇺🇸 United States

Pal International Limited

Manufacturer

2 Importers

GOLD SKY INTERNATIONAL

Manufacturer

🇵🇰 Pakistan