22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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FRED easy Life DSA
Basic UDI-DI
EU MDD
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Eu Md Class 2b
·SCHILLER MEDICAL·1 device
Kaio-Dia
Importer
🇫🇷 France·1 Manufacturer
Blue DNA Companion
Importer
🇫🇷 France
Kaio-Dia
Authorized representative
🇫🇷 France·1 Manufacturer·2023 Devices
Moon Surgical, SAS
Importer
🇫🇷 France·2 Manufacturers
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·May 14, 2025
INNOPHTA - EMGIDI
Importer
🇫🇷 France·4 Manufacturers
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.
FDA Enforcement
Class II
·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
FDA Enforcement
Class II
·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
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
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m)¿¿¿ B13111027, n)¿¿¿¿ B13111034, o)¿¿¿¿ B13111035, p)¿¿¿¿ B13111036; intervertebral fusion device - cervical
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical
FDA Enforcement
Class II
·Ongoing·Medicrea International·August 30, 2023