2,701 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Ireland
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ET L-Bracket (Pair)
Device
EU MDR
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Eu Md Class 1
·Trulife·On the market·26 countries
PAVLIK HARNESS WHITE NO BOOTEES L
Device
EU MDR
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Eu Md Class 1
·Trulife·On the market
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·February 12, 2020
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 23, 2020
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 23, 2020
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·July 27, 2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·July 27, 2022
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018
Multichem MS ISDs Level 1
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Techno-path Manufacturing Ltd.·2 devices
KEWS300
Basic UDI-DI
EU MDD
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Eu Md Class 2b
·Syncrophi Systems Ltd·1 device
Multichem AMH Assayed Level 3
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Assayed Level 2
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Assayed Level 1
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Unassayed Level 3
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Unassayed Level 2
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Unassayed Level 1
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Assayed Tri level Mini-Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Unassayed Tri level Mini-Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Unassayed Tri level
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device
Multichem AMH Assayed Tri level
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Techno-path Manufacturing Ltd.·1 device