22 results
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30ms
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Sources: EU EUDAMED, US FDA
APQ HEALTH INC
FDA registration
APQ HEALTH INC·1 product·🇺🇸 United States
Autoplaque
FDA UDI
APQ HEALTH INC.·00860014730009·Autoplaque software performs post-processing o...
Navik 3D
FDA UDI
APN HEALTH·00869781000308·Navik 3D™ is a multi-component computer system ...
APOHEALTH Ear Wax Drops
Device
EU MDD
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Eu Md Class 2a
·Gofarm Sp. z o.o. Sp. k.·On the market·1 country
BIOTRUE MULTI-PURPOSE SOLUTION
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code LYL·April 21, 2014
SHIELD GLOVES
FDA Adverse Event
Other
·APO HEALTH·Product code LYY·January 21, 1994
Navik 3D v2, REF NAVIK3D, 3D Mapping System
FDA Recall
Open, Classified
·APN Health LLC·Product code DQK·November 7, 2023
Navik 3D v2, REF NAVIK3D, 3D Mapping System
FDA Enforcement
Class III
·Ongoing·APN Health LLC·December 20, 2023
Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
FDA Recall
Terminated
·Pivotal Health Solutions·Product code ILY·December 17, 2014
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
FDA Recall
Open, Classified
·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023
PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
FDA Recall
Open, Classified
·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
FDA Recall
Open, Classified
·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
FDA Recall
Open, Classified
·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023
European Healthcare & Device Solutions Ltd.
Authorized representative
🇮🇪 Ireland·66 Manufacturers·867 Devices
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10
FDA Recall
Open, Classified
·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023
DENTSTORE SRL
Importer
🇷🇴 Romania·34 Manufacturers
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices