13 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·November 13, 2024
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·August 13, 2025
SIGNA Creator, SIGNA Explorer, NMRI systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·March 5, 2025
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 6) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Achieva XR Product Numbers: (1) 781153, (2) 781253;
FDA Enforcement
Class II
·Ongoing·Philips North America·June 18, 2025
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
FDA Enforcement
Class II
·Ongoing·ZOLL Medical Corporation·March 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
FDA Enforcement
Class II
·Ongoing·ZOLL Medical Corporation·March 19, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025