Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

FDA 510(k)

FDA Class 1 ·Physical Medicine

Portable Folding Electric Wheelchair (Model: DC01)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Power Wheelchair (D26)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Disposable Medical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Electric Scooter

FDA 510(k)

FDA Class 2 ·Physical Medicine

Power Wheelchair (D10, D12, D15, D17, D20, D37)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Power Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Power Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Home Monitoring

FDA registration

BIOTRONIK SE & CO. KG·11 products·🇩🇪 Germany

JFA STERILE NON WOVEN SWAB, 4PLY 10X20CM

Device

EU MDR · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·On the market

JFA assorted bandage dressings - Pack of 12

Device

EU MDR · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·On the market

G40-Gutta Percha Points-GAPA-J JFL

Device

EU MDR · Eu Md Class 2a ·TIANJIN GAPADENT CO., LTD·On the market·32 countries

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS

HMSC Version 3.63

FDA registration

BIOTRONIK, INC.·11 products·🇺🇸 United States

JFA ADHESIVE WOUND DRESSING 10X20CM BOX OF 25PCS

Device

EU MDR · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·On the market

JFA Nitrile Gloves - Blue, Large - Insert for FAK

Device

EU MDR · Eu Md Class 1 ·Shandong Blue Sail Health Technology Co.,Ltd·On the market

446470 IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent

FDA registration

BECKMAN COULTER, INC.·3 products·🇺🇸 United States

SPIFE IFE Pentavalent Kits

FDA registration

HELENA LABORATORIES, CORP.·3 products·🇺🇸 United States

446470 IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent

FDA registration

BECKMAN COULTER, INC.·3 products·🇺🇸 United States