11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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BAL Créations
Manufacturer
🇫🇷 France
Remedee wristband OA
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Remedee Labs SA·2 devices
Easy BAL Clip
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Axess Vision Technology·1 device
sthemO Heparin cal
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Diagnostica Stago·1 device
sthemO FDP cal
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Diagnostica Stago·1 device
sthemO VWF cal
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Diagnostica Stago·1 device
Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.
FDA Enforcement
Class II
·Terminated·Medicrea International·March 18, 2020
Opale
Authorized representative
🇫🇷 France·1 Manufacturer·1 Device
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PARAFUSO PEDICULAR POLIAXIAL 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, WIELOOSIOWA SRUBA TRANSPEDIKULARNA 7.5MM x 45MM, (01)03613720177906(10)19A0630(17)290103, RX only
FDA Enforcement
Class II
·Terminated·Medicrea International·January 8, 2020
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560 B36008535 B36008540 B36008545 B36008550 B36008555 B36008560 B36009535 B36009540 B36009545 B36009550 B36009555 B36009560 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.
FDA Enforcement
Class II
·Terminated·Medicrea International·March 18, 2020
FF1-210 BALANCIER SANS CHARGES (BAL FF1-209)
Basic UDI-DI
EU MDD
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Eu Md Class 1
·ETABLISSEMENTS FRANCO ET FILS·1 device