BEUDAMED
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    SYLVAN PEDIASCAN 200 TRANSILLUMINATOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Junior Flexi Tip Pediatric Enema Tip

    FDA UDI
    Bracco Diagnostics Inc.·10815112021532·Junior Flexi Tip

    Junior Flexi Tip Pediatric Enema Tip

    FDA UDI
    Bracco Diagnostics Inc.·10815112021075·Junior Flexi Tip

    MICRO SCISSORS INSERT

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929013090·MICRO SCISSORS CURVED SINGLE-ACTION JAW FOR TUB...

    REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250

    FDA 510(k)
    FDA Class 2 ·Dental

    G7 SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·August 8, 2018

    G7 SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·August 8, 2018

    G7 SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·August 8, 2018

    OT VERIO IQ METER

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

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·January 8, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 17, 2010

    Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·December 12, 2018

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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