BEUDAMED
    135 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

    FDA Enforcement
    Class II ·Ongoing·SURGICAL SPECIALTIES·April 24, 2024

    MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·May 27, 2026

    BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·December 17, 2025

    BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·December 17, 2025

    Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·December 17, 2025

    BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·December 17, 2025

    SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 24, 2025

    SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 24, 2025

    SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 24, 2025

    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 3, 2025

    REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·July 9, 2025

    BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·July 9, 2025

    BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·July 9, 2025

    Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·June 26, 2024

    Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·June 14, 2023

    Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·June 14, 2023

    Sensica Urine Output System

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·July 6, 2022

    Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·April 18, 2018