BEUDAMED
    26 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 29, 2025

    DeRoyal CNRV SPINAL PACK, REF 89-10532.03

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·December 21, 2022

    DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·December 21, 2022

    Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 29, 2025

    Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·June 14, 2023

    (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888264960, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888264986, Sterile;

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 2, 2024

    (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888266130, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888266148, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 2, 2024

    Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp.

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·June 14, 2023

    Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 18 Fr/Ch 8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36" 266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 29, 2025

    DR 800. Digital Radiography X-ray System.

    FDA Enforcement
    Class II ·Ongoing·Agfa N.V.·September 4, 2024

    Barco MDSC-8527 NXF, Part Number K9352421

    FDA Enforcement
    Class II ·Ongoing·Barco N.V.·February 14, 2024

    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

    FDA Enforcement
    Class II ·Ongoing·Agfa N.V.·April 10, 2024

    Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system

    FDA Enforcement
    Class II ·Ongoing·Barco N.V.·July 2, 2025

    Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm) 5558264957 Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm) 5558264965 Salem Sump" TUBE 16 Fr/Ch (5.3 mm) 5558264973 Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm) 5558264981 Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm) 8888264911 Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm) 8888268060 Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm) 8888268086 Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 29, 2025

    V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

    FDA Enforcement
    Class II ·Ongoing·Vital Scientific N.V.·December 4, 2019

    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Enforcement
    Class II ·Ongoing·Vital Scientific N.V.·October 2, 2019

    Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm SKUs not distributed in US

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 29, 2025

    Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm) 8888265132 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm) 8888265140 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm) 8888266213 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm) 8888266221 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm) 8888266247 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm) 8888266262 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm) 8888266288 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm)

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 29, 2025

    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024