721 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Servo-u MR Ventilator System. Model Number: 6888800.
FDA Enforcement
Class I
·Ongoing·Maquet Critical Care AB·July 9, 2025
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 11, 2025
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
FDA Enforcement
Class I
·Terminated·DeRoyal Industries Inc·June 16, 2021
ASM Replacement Battery, Component Number SUB0000594
FDA Enforcement
Class I
·Ongoing·ICU Medical Inc·May 24, 2023
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
FDA Enforcement
Class I
·Terminated·ev3 Inc.·March 16, 2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
FDA Enforcement
Class I
·Terminated·ev3 Inc.·March 16, 2022
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
FDA Enforcement
Class I
·Ongoing·C.R. Bard Inc·May 28, 2025
Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
FDA Enforcement
Class I
·Ongoing·C.R. Bard Inc·May 28, 2025
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
FDA Enforcement
Class I
·Ongoing·C.R. Bard Inc·May 28, 2025
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
FDA Enforcement
Class I
·Ongoing·C.R. Bard Inc·May 28, 2025
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 24, 2024
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
FDA Enforcement
Class I
·Ongoing·Mercury Enterprises, Inc. dba Mercury Medical·October 9, 2024
Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·October 11, 2023
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
FDA Enforcement
Class I
·Ongoing·B Braun Medical Inc·April 22, 2026
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
FDA Enforcement
Class I
·Ongoing·Trokamed GmbH·January 22, 2025
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
FDA Enforcement
Class I
·Ongoing·Trokamed GmbH·January 22, 2025
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
FDA Enforcement
Class I
·Ongoing·Trokamed GmbH·January 22, 2025
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
FDA Enforcement
Class I
·Ongoing·Trokamed GmbH·January 22, 2025
ASM Replacement Battery, Component Number SUB0000864
FDA Enforcement
Class I
·Ongoing·ICU Medical Inc·May 24, 2023