BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    PV-CERAMIC, CERAMINIQUE

    FDA 510(k)
    FDA Class 2 ·Dental

    CLAW GRASPING & EXTRACTING FORCEP INSERT

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929012610·CLAW GRASPING & EXTRACTING FORCEPS DOUBLE-ACTIO...

    NMI PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    L720 EXAMINATION CHAIR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 17, 2010

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 8, 2013

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·January 15, 2025

    MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

    FDA Recall
    Terminated ·Hemostatix Medical Technologies LLC·Product code GEI·July 27, 2010

    HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF 7013-5050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

    FDA Recall
    Terminated ·Hemostatix Medical Technologies LLC·Product code GEI·July 27, 2010

    ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.

    FDA Recall
    Terminated ·Memphis Fertility Laboratory Inc·Product code NUC·July 10, 2009

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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