BEUDAMED
    4,359 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03

    FDA Recall
    Terminated ·TZ Medical Inc.·Product code FRO·October 14, 2015

    smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

    smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

    smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

    3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FRO·May 25, 2022

    ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code FRO·November 15, 2022

    smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

    smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code DRO·March 10, 2020

    20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

    FDA Recall
    Terminated ·CellEra LLC·Product code FRO·December 15, 2021

    a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Model Number: 00303E. b. DERMARITE INDUSTRIES DermaCol Ag Silver Collagen Dressing DermaCol/Ag 2 X 2 Inch Square Sterile Model Number: 00502E

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FRO·May 25, 2022

    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    FDA Recall
    Terminated ·Z-Medica, LLC·Product code FRO·May 17, 2017

    Brand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025

    TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mr-Guided Focused Ultrasound System

    FDA classification
    FDA Class 3 ·Mr-Guided Focused Ultrasound System

    Neurosurgical Laser With Mr Thermography

    FDA classification
    FDA Class 2 ·Neurosurgical Laser With Mr Thermography

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA classification
    FDA Class 3 ·Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    Television, Less Than 25kv And Less Than 0.1 Mr/Hr

    FDA classification
    FDA Not Classified ·Television, Less Than 25kv And Less Than 0.1 Mr/Hr

    Portable X-ray system

    FDA Recall
    Open, Classified ·DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of)·Product code EHD·June 19, 2025

    Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led

    FDA classification
    FDA Not Classified ·Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led