BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    SPS-SINGLE PATIENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACCUMESH DEPLOYMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRULINE REINFORCED VALVED INFUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIFECARE PCA 3 V5.06

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·April 16, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·October 25, 2012

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code FZP·August 9, 2007

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021