BEUDAMED
    97 results · 13ms · Sources: EU EUDAMED, US FDA

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    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·December 18, 2019

    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1

    FDA Recall
    Terminated ·Arrow International Inc·Product code BSO·January 15, 2020

    MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.

    FDA Recall
    Terminated ·Medtronic Cardiac Surgery Technologies·Product code FZP·February 25, 2008

    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

    FDA Enforcement
    Class II ·Terminated·Cypress Medical Products LLC·October 24, 2018

    Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.

    FDA Recall
    Terminated ·Caridian BCT, Incorporated·Product code LKN·September 21, 2011

    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

    FDA Recall
    Terminated ·Cypress Medical Products LLC·Product code FMF·September 4, 2018

    Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin

    FDA Recall
    Terminated ·Covidien LLC·Product code FMF·May 21, 2012

    Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" Product ID: 8881511136 Indications for Use: Injection of U-1 00 insulin

    FDA Recall
    Terminated ·Covidien LLC·Product code FMF·May 21, 2012

    Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336 Indications for Use: Injection of U-1 00 insulin

    FDA Recall
    Terminated ·Covidien LLC·Product code FMF·May 21, 2012

    Monoject Insulin Safety Syringe 3/10mL 30 X 5/16" Product ID: 8881511344 Indications for Use: Injection of U-1 00 insulin

    FDA Recall
    Terminated ·Covidien LLC·Product code FMF·May 21, 2012

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    FDA Recall
    Terminated ·NeoCoil, LLC·Product code MOS·June 17, 2016

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·August 10, 2016

    MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·January 15, 2014

    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·January 15, 2014

    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·January 15, 2014

    Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code MEG·July 10, 2013

    Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code MEG·July 10, 2013