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30.04.2025
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Urgent Field Safety Notice for HEMAPATCH WOVEN by InterVascular S.A.S
Product group Non-active implants -
special implants
Reference 14412/25
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29.04.2025
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Urgent Field Safety Notice for Welch Allyn Connex Integrated Wall System, Connex Spot Monitor, Connex Vital Signs Monitor, Spot Vital Signs 4400 Device, Green Series 777 Wall System, DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, 2 Piece Reus by Welch Allyn Inc
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 15080/25
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28.04.2025
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Urgent Field Safety Notice for TufTex Over-the-Wire Embolectomy Catheter, Pruitt Occlusion Catheter, Pruitt Irrigation Occlusion Catheter by LeMaitre Vascular, Inc.
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 15923/25
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28.04.2025
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Urgent Field Safety Notice for RO Medical by Nipro Pure Water GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
dialysis technology
Reference 14940/25
|
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28.04.2025
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Urgent Field Safety Notice for N Latex Free Light Chain lambda by Siemens Healthcare Diagnostics Products GmbH
Product group In-vitro diagnostics -
immunological products
Reference 14338/25
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25.04.2025
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Urgent Field Safety Notice for System 6/7/8/9 Reciprocating / Sternum Saw by Stryker Instruments-a division of Stryker Corp
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 13447/25
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24.04.2025
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Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 15442/25
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24.04.2025
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Direct Healthcare Professional Communication on Opzelura 15 mg/g cream: Important information regarding presence of particles in Opzelura cream
Active substance: Ruxolitinib phosphate
The company Incyte Biosciences Distribution B.V. informs about possible particles in Opzelura 15 mg/g cream, which may form during production from the active substance.
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23.04.2025
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Urgent Field Safety Notice for OTNI 17 Luci Connector by OTN Innovations B.V
Product group Orthopaedic / Rehabilitation technology -
prostheses (exoprostheses)
Reference 14725/25
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23.04.2025
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Urgent Field Safety Notice for VasoView Hemopro 2 by Maquet Cardiovascular
Product group Optics / Precision engineering -
endoscopes
Reference 14539/25
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|
23.04.2025
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Urgent Field Safety Notice for GOT Multi (SF6, C2F6, C3F8) by AL.CHI.MI.A. S.R.L.
Product group ophthalmological technology -
liquid media for ophthalmological purposes
Reference 14313/25
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|
23.04.2025
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Urgent Field Safety Notice for Eye wick by GRI Medical & Electronic Technology Co., Ltd.
Product group Dressings / Pads -
swabs, sponges, wipes, swabsticks
Reference 15470/25
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23.04.2025
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Urgent Field Safety Notice for Soltive Laser System by Gyrus ACMI, Inc.
Product group Optics / Precision engineering -
laser technology
Reference 13407/25
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22.04.2025
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Processing statistics
Here the BfArM publishes the current processing statistics of authorisations and registrations as well as of renewals. The figures are updated on a monthly basis.
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22.04.2025
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Current processing statistics of the BfArM
State: March 2025
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22.04.2025
|
Marketable medicinal products in the responsibility of the BfArM
On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are updated on a monthly basis.
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22.04.2025
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Urgent Field Safety Notice for Xpert BCR/ABL Ultra, Xpert BCR/ABL Ultra p190 by Cepheid
Product group In-vitro diagnostics -
immunological products
Reference 15288/25
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22.04.2025
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Direct Healthcare Professional Communication (DHPC) on Livopan (Nitrous Oxide/Oxygen) 50 %/50 % gas for medical use, compressed: Risk of gas leakage and interruption of gas supply to patients when the flow rate is above 8 l/min
Active substance: Nitrous Oxide, Oxygen
The company Linde Sverige AB informs about a quality defect of the medicinal product Livopan when used with a Fir Tree connector for direct connection with O2/N2O breathing systems.
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17.04.2025
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Urgent Field Safety Notice for Tornado Embolization MicrocoilT by Cook Incorporated
Product group Non-active implants -
special implants
Reference 15052/25
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17.04.2025
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Urgent Field Safety Notice for Centricity High Acuity (CHA) C.C and Anesthesia by GE Healthcare Finland Oy
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 15159/25
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