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