BEUDAMED
    58 results · 10ms · Sources: EU EUDAMED, US FDA

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    Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile

    FDA Recall
    Terminated ·QLT USA, Inc.·Product code LYC·January 26, 2006

    Invacare 2G Tarsys Seating System, Model 2GT.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014

    Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435. The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint.

    FDA Recall
    Terminated ·Tornier, Inc.·Product code KWH·April 6, 2009

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·January 6, 2014

    VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIX·October 13, 2011

    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

    FDA Recall
    Terminated ·Covidien LLC·Product code NGT·August 16, 2013

    MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123

    FDA Recall
    Terminated ·Product code NGT·November 15, 2010

    0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code NGT·July 25, 2014

    Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

    FDA Recall
    Terminated ·Covidien LLC·Product code NGT·August 6, 2015

    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

    FDA Recall
    Terminated ·Covidien LLC·Product code NGT·August 6, 2015

    MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 3 ml in 12 ml syringe Item code 8881590123

    FDA Recall
    Terminated ·Product code NGT·November 15, 2010

    Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code NGT·September 30, 2013

    MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 10 ml in 12 ml syringe Item code 8881590121

    FDA Recall
    Terminated ·Product code NGT·November 15, 2010

    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

    FDA Recall
    Terminated ·Covidien LLC·Product code NGT·August 16, 2013

    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

    FDA Recall
    Terminated ·MRP, LLC dba AMUSA·Product code NGT·April 27, 2015

    Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code NGT·July 30, 2007

    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.

    FDA Recall
    Terminated ·Amsino Medical USA·Product code NGT·August 15, 2012

    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code NGT·September 14, 2012

    Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

    FDA Recall
    Terminated ·Covidien LLC·Product code NGT·August 16, 2013