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    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

    FDA Enforcement
    Class II ·Ongoing·Galt Medical Corporation·June 21, 2023

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·HF Acquisition Co LLC·June 17, 2026

    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

    FDA Enforcement
    Class II ·Ongoing·Fujifilm Irvine Scientific, Inc.·November 24, 2021

    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-DCOS Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 9 x 1 mL Equilibration Solution- ES; 9 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

    FDA Enforcement
    Class II ·Ongoing·Fujifilm Irvine Scientific, Inc.·November 24, 2021

    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    FDA Enforcement
    Class II ·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017

    VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    FDA Enforcement
    Class II ·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017

    Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00 -SmartSite Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01 -Infusion Set Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN, FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion 630-00650 Rev 00 Production Usage: Administration sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male luer with spin lock and tubing with different length of tubing.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·November 14, 2018

    BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D; REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV; REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M; REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV; REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV; REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M; REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV; REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV; REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M; REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV; REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV; REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M; REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M; REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M REF: 11419365, BD Alaris" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite" Y-sites REF: 10813621, BD Alaris" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 2423-0007, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 10015896, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite" Y-sites REF: 24010-0007T, BD Alaris" Pump Infusion Set, Bonded Texium", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite" Y-sites REF: 10010483, BD Alaris" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing REF: 2403-0007, BD Alaris" Pump Infusion Set, Half Set, SmartSite" Y-site REF: 24301-0007T, BD Alaris" Pump Infusion Set, SmartSite" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium" Closed Male Luer with Priming Cap, SmartSite" Y-site

    FDA Enforcement
    Class I ·Ongoing·CareFusion 303, Inc.·August 13, 2025

    Temporary Titanium Abutments

    FDA Enforcement
    Class II ·Ongoing·DDS Lab·February 12, 2025

    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

    FDA Enforcement
    Class II ·Ongoing·Drs Vascular, Inc·August 27, 2025

    Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S-606 SOFSILK* 0 BLK 2X150CM PCT X36 S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 S-610 SOFSILK* 5 BLK 2X150CM PCT X12 SOFSILK 2-0 30 BK CV-24 GS453-2 SOFSLK 4-0 24 BK CV-15 DA VS581-2 ***Added 4/1/24*** CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA S-282 SOFSILK* 5 BLK 3X60CM PCT X36 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA 3226-31 TICRON* 4-0 BLU 60CM CV330 DA 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863087-31 TICRON* 4-0 BLU 75CM CV33DA 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863147-83 TICRON 2 BLU 5X75CM KV37X12 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-31 TICRON* 4-0 BLU 75CM CV331 88863226-31 TICRON* 4-0 BLU 60CM CV330DA 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863229-31 TICRON* 4-0 BLU 75CM CV307DA 88863271-31 TICRON* 4-0 BLU 90CM CV331DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12

    FDA Enforcement
    Class II ·Ongoing·Covidien LP·February 7, 2024

    Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·December 3, 2025

    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·December 24, 2025

    Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·December 3, 2025

    BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·October 1, 2025

    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·September 11, 2024

    Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·September 11, 2024

    Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·September 11, 2024

    Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·September 11, 2024