BEUDAMED
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    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 81 IN W/ 32 IN EXT SET; Catalog Number: 490329.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR, 92 IN W/EXT SET 9 IN.; Catalog Number: 490489.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15DR, CARESITE LAD, 116 IN; Catalog Number: 490522. 2. IV ADMIN SET 115, IN. W. 9 IN EXT SET; Catalog Number: 490568.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,MEM HLTHCARE, REF 60035977; 6) MTS,LEFT HEART,KIT,J*,M*,C*, REF 60040273; 7) MTS,LEFT HEART,KIT,C*,C*, REF 60100313; 8) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 9) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 10) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 11) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 12) MTS,LEFT HEART,MAN,KIT,S*-BALTIMORE, REF 60190947; 13) MTS-LEFT HEART,KIT-W*,H* HOSP PG, REF 60231052; 14) MTO,3-VALVE,KIT-T*,A*-PG, REF 65190182; 15) MTO,LEFT HEART,KIT,-,S* F*,-,PG, REF 65190474; 16) MTS,DR.,MCKAYS,4V,KIT,-,H* HOSP PG, REF 600800516; 17) MTS,EP,KIT,-,S*,TEACHING HOSPITAL PG, REF 601309013; 18) MTS,RHT,HRT-S* HOSP &,MC, REF 601905413; 19) MTS,PEDS,LFT,&,RT,HRT-S* HOSP, REF 601905414; 20) MTO,SCH,BEL,J*,H*-ST-PAUL,-,PG, REF 606604328; 21) LHK,-,MID,3VCOMP,OFF,PS,S10RA, REF 613000122; 22) MTS,LHK,W* HOSPITAL, REF 6010034281; 23) MTS,LHK,W* HOSPITAL, REF 6010034281; 24) MTS,LHK,P*,P* MED CTR, REF 6010171931; 25) MTS,LHK,M* HEALTHCARE,MGMT, REF 6061073001; 26) TVR US B* INTEGRATED SERVICE CENT, REF 601316711A; 27) LHK-S* MEDICAL CENTER,A*, REF 60190776A; 28) LHK,-,S*,AND,W* HOSPITAL, REF 60191118A.

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

    MOSAIQ Oncology Information System

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·June 17, 2026

    CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Dexcom, Inc.·May 20, 2026

    3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·May 20, 2026

    LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm

    FDA Enforcement
    Class II ·Ongoing·MICROVENTION INC.·May 20, 2026

    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Dexcom, Inc.·May 20, 2026

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·May 20, 2026

    Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Dexcom, Inc.·May 20, 2026

    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026