BEUDAMED
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    Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·September 8, 2021

    Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA GRY, RPLCE LD SET WAM/AM12 LIMBS BANA IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 BANA IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRY, LEAD SET AM15E 13-WIRE BANANA AHA GRAY, LEAD SET AM15E 13-WIRE BANANA IEC GRAY, RPLCE LEAD SET AM15E E2-E4 BANANA AHA GRAY, LEAD SET WAM 10 WIRE CLIPS AHA GRAY, LEAD SET WAM 10 WIRE CLIPS IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRY, RPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY, LEAD SET WAM/AM12 10-WIRE BANANA AHA GRY, LEAD SET WAM/AM12 10-WIRE BANANA IEC GRY, LD SET WAM/AM12 10 WRE SHORT AHA CLIP, LD SET WAM/AM12 10 WRE SHORT IEC CLIP.

    FDA Enforcement
    Class II ·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020

    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)

    FDA Enforcement
    Class II ·Terminated·BEMER INT. AG·February 17, 2021

    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·March 22, 2017

    Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·June 13, 2018

    HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Enforcement
    Class II ·Terminated·Specialty Appliance Works, Inc.·April 29, 2015

    Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TRAY SUT1113A SUTURING SET SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST. SUT11515 LACERATION TRAY SUT11540A LACERATION TRAY SUT11590 SUTURE SET SUT11775 LACERATION TRAY SUT11780 MINOR TRAY SUT1189B LACERATION TRAY SUT11900 SUTURE TRAY SUT11910 LACERATION TRAY SUT11965 SUTURE SET SUT11970 SUTURE TRAY SUT12025 LACERATION TRAY SUT12225 SUTURE TRAY REGULAR SUT12275 SUTURING SET SUT12335 LACERATION TRAY SUT12625 SNAGFREE LACERATION TRAY SUT12765 SNAGFREE LACERATION TRAY SUT12895 SUTURE SET SUT12895 SUTURE SET SUT12895 SUTURE SET SUT12970 PLASTIC TRAY SUT13315 LACERATION TRAY SUT13400 SNAG FREE PLASTICS TRAY W/OR INSTRUMENTS SUT13510 LACERATION TRAY SUT13535 PLASTICS SUTURE TRAY SUT13550 LACERATION TRAY SUT13555 SUTURE TRAY SUT13620 LACERATION TRAY SUT13620 LACERATION TRAY SUT13720 LACERATION TRAY SUT13785 PLASTIC SUTURE TRAY SUT13830 LACERATION TRAY SUT13975 LACERATION TRAY SUT14000 ER SUTURE TRAY SUT14125 SUTURE SET W/SNAGFREE NEEDLEHOLDER SUT14125 SUTURE SET W/SNAGFREE NEEDLEHOLDER SUT14305 LACERATION TRAY SUT14355 SNAG FREE SUTURE TRAY SUT14370 ER FACIAL TRAY SUT14435 LACERATION TRAY W/ SAFETY NEEDLE SUT14655 LACERATION TRAY SUT14705 LACERATION TRAY SUT14730 MINOR SUTURE SET/ I&D TRAY SUT14730 MINOR SUTURE SET/ I&D TRAY SUT14800 NASAL SET SUT14805 TRACH SET SUT15085 LACERATION/INCISION & DRAINAGE TRAY SUT15140 LACERATION TRAY SUT15215 SNAG FREE LACERATION TRAY SUT15225 LACERATION TRAY SUT15255 LACERATION TRAY SUT15375 SUTURING SET SUT15390 SUTURE KIT SUT15430 ER SMALL SET SUT15525 SUTURE TRAY SUT15695 SUTURE SET SUT15735 SUTURE SET SUT15870 SUTURE SET SUT17015 SNAG FREE LACERATION TRAY SUT17015 SNAG FREE LACERATION TRAY SUT17080 RADIOLOGY LACERATION TRAY SUT17145 LACERATION TRAY SUT17155 LACERATION TRAY SUT17275 SUTURE SET SUT17500 SUTURE SET SUT17595 SNAGFREE LACERATION TRAY SUT17620 SUTURE TRAY SUT17620 SUTURE TRAY SUT17860 FINE PLASTICS TRAY SUT18150 LACERATION TRAY SUT18160 LACERATION TRAY SUT18160 LACERATION TRAY SUT18310 SNAGFREE LACERATION TRAY SUT18370 LACERATION TRAY SUT18425 TOENAIL EXCISION TRAY SUT18505 LACERATION TRAY SUT18510 SPECIALTY PLASTICS TRAY SUT18570 LACERATION TRAY SUT18655 FINE PLASTICS TRAY SUT18695 LACERATION TRAY SUT18765 LACERATION TRAY SUT18770 FINE PLASTIC SUTURE SET SUT18775 LACERATION TRAY SUT18810 SNAGFREE LACERATION TRAY SUT18890 LACERATION TRAY SUT18920 DR. DACEY SURGERY PACK SUT18920 DR. DACEY SURGERY PACK SUT18920 DR. DACEY SURGERY PACK SUT19050 LACERATION TRAY SUT19120 DERM SURGERY PACK SUT19170 TOENAIL KIT SUT19290A LACERATION TRAY SUT19340 LACERATION TRAY SUT19395 LACERATION TRAY SUT19450 SUTURE SET SUT19525 PLASTICS - PROCEDURE PACK SUT19615 PLASTICS SUTURE TRAY SUT19675 WOUND CLOSURE TRAY SUT19675 WOUND CLOSURE TRAY SUT20105 NAIL TRAY SUT20375 RECYCLABLE DERMATOLOGY MINOR SURGERY SET SUT20410 LACERATION TRAY SUT20410 LACERATION TRAY SUT20460 LACERATION TRAY SUT20500 LACERATION TRAY W/SNAGFREE NEEDLEHOLDER SUT20700 LACERATION TRAY SUT20745 LACERATION TRAY SUT20760 Wound Closure Tray SUT20780 CENTRAL LINE CATH KIT SUT20835 LACERATION TRAY SUT20965 LACERATION TRAY SUT20995 LACERATION TRAY SUT21010 DEBRIDEMENT TRAY SUT21015 PLASTIC SURGERY TRAY SUT21065 LACERATION TRAY SUT2220 LACERATION TRAY SUT2220 LACERATION TRAY SUT2750 SUTURING SET SUT2820 SUTURING SET SUT3100 FACIAL SUTURING SET SUT3780L LACERATION TRAY SUT5765 SUTURING SET SUT5765 SUTURING SET SUT6100 PLASTIC SUTURE GILLIES TRAY SUT6515 ST. JOSEPH ALL PURPOSE TRAY SUT6760 SUTURE TRAY SUT6960 CUSTOM LACERATION TRAY SUT6960 CUSTOM LACERATION TRAY SUT7980 LACERATION TRAY SUT8165 LACERATION TRAY SUT8295 LACERATION TRAY SUT8445 SATIN PLASTICS WOUND CLOSURE TRAY SUT8795 SUTURING SET SUT9005 SUTURING SET SUT9140

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

    FDA Enforcement
    Class II ·Terminated·Gambro Renal Products, Incorporated·April 23, 2014

    9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·February 15, 2017

    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

    FDA Enforcement
    Class II ·Terminated·Nipro Medical Corporation·May 23, 2018

    CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·October 2, 2013

    SmartSite Extension Set, Model No. 20029E, intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·April 23, 2014

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 1, 2015

    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·October 2, 2013

    Luer Lock Set - Catalog # MPC-125, for IV administration sets.

    FDA Enforcement
    Class II ·Terminated·Molded Products Inc·August 28, 2019

    STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·March 14, 2018

    SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·February 11, 2015