29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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A2L® TRIAL CAGE
Device
EU MDD
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Eu Md Class 2a
·EUROSPINE SARL·On the market·1 country
inHEART Portal
Device
EU MDR
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Eu Md Class 1
·inHEART·On the market·10 countries
MI SCREW Ø4 lg 34mm
Device
EU MDD
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Eu Md Class 2b
·Ortho Cape·On the market·32 countries
Soluscope SAS
Manufacturer
🇫🇷 France·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
A2L trial cage, non-sterile
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·EUROSPINE SARL·1 device
Soluscope PAA
Device
EU MDD
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Eu Md Class 2b
·Soluscope SAS·On the market·7 countries
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
FDA Enforcement
Class III
·Terminated·Technidata S.A.·July 24, 2013
TD-Synergy. Laboratory Information System.
FDA Enforcement
Class II
·Terminated·Technidata S.A.·May 29, 2013
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
FDA Enforcement
Class II
·Terminated·MEDICAMAT S.A.·March 12, 2014
TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
FDA Enforcement
Class III
·Terminated·Technidata S.A.·April 9, 2014
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
FDA Enforcement
Class II
·Terminated·Kiscomedica S.A.·March 22, 2017
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
FDA Enforcement
Class II
·Ongoing·Technidata S.A.·May 17, 2023
Synergie Ingénierie Médicale
Importer
🇫🇷 France·1 Manufacturer
Symbios France SAS
Importer
🇫🇷 France·1 Manufacturer
Haemonetics France SARL
Importer
🇫🇷 France·2 Manufacturers
12974
Certificate
MDD Annex II (excluding section 4)·S.A. GERMITEC·GMED SAS·1 Basic UDI-DI
Novacyt S.A.
Importer
🇫🇷 France
GE Medical Systems SCS
Authorized representative
🇫🇷 France·27 Manufacturers·564 Devices