BEUDAMED
    67 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I ×

    FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

    FDA Enforcement
    Class I ·Terminated·Avid Medical, Inc.·June 16, 2021

    DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.

    FDA Enforcement
    Class I ·Terminated·Avid Medical, Inc.·June 16, 2021

    Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5" Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch GoPump Kit 510205BP, 5" Fenestrated catheter & Biopatch GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch GoBlock kit 510608 Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

    FDA Enforcement
    Class I ·Terminated·Deroyal Industries, Inc. Lafollette·October 6, 2021

    Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.

    FDA Enforcement
    Class I ·Terminated·Ethicon, Inc.·November 28, 2012

    Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH GoPump Kit 510110, w/2.5" Fenestrated Catheter GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.

    FDA Enforcement
    Class I ·Terminated·Convatec Inc.·June 25, 2014

    Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    FDA Enforcement
    Class I ·Ongoing·SML Distribution, LLC·May 11, 2022

    ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.

    FDA Enforcement
    Class I ·Terminated·Ethicon, Inc.·November 28, 2012

    Kit: Midline Insertion DA. MAI Kit Part Number: 77981B

    FDA Enforcement
    Class I ·Terminated·Medical Action Industries, Inc. 306·May 19, 2021

    Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit 510141-BP,10" fenestrated catheter& BIOPATCH Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.

    FDA Enforcement
    Class I ·Terminated·Cook, Inc.·May 22, 2013

    Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable Single Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    FDA Enforcement
    Class I ·Ongoing·Universal Meditech Inc.·February 8, 2023

    Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013