6,859 results · 46ms · Sources: EU EUDAMED, US FDA

LOW VISION ENHANCEMENT SYSTEM (LVES)

FDA 510(k)
FDA Class 1 ·Ophthalmic

BTG SMARTEST GLUCOSE TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Guangzhou HEAS BioTech Co., Ltd.

Manufacturer
🇨🇳 China

MetaOptima Technology Inc.

Manufacturer
🇨🇦 Canada·1 Importer

Xiamen Wiz Biotech Co., Ltd.

Manufacturer
🇨🇳 China·4 Basic UDI-DIs·4 Devices·1 Importer

Pall International SARL

Manufacturer
🇨🇭 Switzerland·1 Importer

bioLytical Laboratories Inc.

Manufacturer
🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR

Lábujjtámasztó-M

Device
EU MDR · Eu Md Class 1 ·Berkemann Hungary Bt.·On the market·10 countries

Lábujjtámasztó-L

Device
EU MDR · Eu Md Class 1 ·Berkemann Hungary Bt.·On the market

Lábujjpárna lábujjfixálóval L-bal

Device
EU MDR · Eu Md Class 1 ·Berkemann Hungary Bt.·On the market·10 countries

Lábujjpárna lábujjfixálóval L- jobb

Device
EU MDR · Eu Md Class 1 ·Berkemann Hungary Bt.·On the market·10 countries

Lábujjpárna lábujjfixálóval M-jobb

Device
EU MDR · Eu Md Class 1 ·Berkemann Hungary Bt.·On the market·10 countries

Lábujjpárna lábujjfixálóval M-bal

Device
EU MDR · Eu Md Class 1 ·Berkemann Hungary Bt.·On the market·10 countries

Lábujjpárna lábujjfixálóval-S-jobb

Device
EU MDR · Eu Md Class 1 ·Berkemann Hungary Bt.·On the market·10 countries