426 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
FDA Enforcement
Class II
·Ongoing·Orthorebirth Co Ltd·May 13, 2026
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
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
FDA Enforcement
Class II
·Ongoing·Orthorebirth 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
Portable X-ray system
FDA Enforcement
Class II
·Ongoing·DIGIMED CO., LTD·July 30, 2025
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
FDA Enforcement
Class II
·Ongoing·CORENTEC CO., LTD·June 12, 2024
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA Enforcement
Class II
·Ongoing·CORENTEC CO., LTD·June 12, 2024
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
FDA Enforcement
Class II
·Terminated·CORENTEC CO., LTD·March 22, 2017
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
FDA Enforcement
Class II
·Terminated·IntroMedic Co., Ltd.·May 9, 2018
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
FDA Enforcement
Class II
·Terminated·Mediana Co., Ltd.·July 8, 2020
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
FDA Enforcement
Class II
·Terminated·Mediana Co., Ltd.·July 28, 2021
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step P in vitro diagnostic test REF: 8194
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 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