16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Chemfort® Catheter Adaptor
FDA 510(k)
FDA Class 2
·General Hospital
BD BBL™ Sensi-Disc™ Doxycycline 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312865·BD BBL™ Sensi-Disc™ Doxycycline 30 µg
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022700·Dornier 400 µm Single-Use SMA Diode Laser Fiber...
SYRINGE 0.5ML 30GA 8MM 10BAG 500CAS AP
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 22, 2020
BD SYRINGE 0.5ML 30GA 8MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 12, 2020
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRIMATRIX DERMAL REPAIR SCAFFOLD
FDA 510(k)
FDA Unclassified
·Unknown
INTIMA-II 24GAX0.75IN PRN SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 18, 2021
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·April 19, 2021
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ILS·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 17, 2013
TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·February 20, 2025
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 722011. 7. Allura Xper FD20, Model Number 722012. 8. Allura Xper FD20 Biplane, Model Number 722013. 9. Allura Xper FD20 OR Table, Model Number 722023. 10. Allura Xper FD10, Model Number 722026. 11. Allura Xper FD10/10, Model Number 722027. 12. Allura Xper FD20, Model Number 722028. 13. Allura Xper FD20/10, Model Number 722029. 14. Allura Xper FD20 OR Table, Model Number 722035. 15. Allura Xper FD20/20, Model Number 722038. 16. Allura Xper FD20/15, Model Number 722058. 510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014