405 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Extended Tip Applicator 8CM, Box of 1.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025
Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
FDA Enforcement
Class II
·Ongoing·Guangzhou Improve Medical Instruments Co., Ltd.·August 22, 2018
Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
FDA Enforcement
Class II
·Ongoing·Guangzhou Improve Medical Instruments Co., Ltd.·May 1, 2019
One Step K in vitro diagnostic test REF: 81A4
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step 10A in vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step UTI in vitro diagnostic test REF: 3374
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
Uric Acid in vitro diagnostic test REF: 31H0P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step pH in vitro diagnostic test REF: 31I4P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
CLARITY II Laser System; Model No. 1110200210.
FDA Enforcement
Class II
·Ongoing·Lutronic Corporation·March 18, 2026
Genesis Push-In Suture Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Fixone Biocomposite Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Knotless Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Dual Thread Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
AlternatiV+ Max Knotless Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
AlternatiV+ Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Fixone Hybrid Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
XERF EFFECTOR 60. Electrosurgical unit.
FDA Enforcement
Class II
·Ongoing·Lutronic Corporation·October 22, 2025