49 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QScreen
FDA 510(k)
FDA Class 2
·Neurology
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005039·Cassette - Filterless, Spike
ambIT* Cassette - Filterless, Spike
FDA UDI
Avanos Medical, Inc.·00193494001087·ambIT* Cassette - Filterless, Spike
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327090192·Blade f. 6514-7-200, 2.0/2.3mm
LINK Instruments - Alignment and positioning instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575342006·Orthopaedic instrument surgical connector - LIN...
Medical surgical mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
FDA 510(k)
FDA Class 2
·Ophthalmic
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 26, 2020
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 3, 2014
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALARM
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 8, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4MM, UPPERFACE, (5/PACKAGE)
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER FREIBURG·Product code HRS·July 14, 2017
BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4MM, UPPERFACE, (5/PACKAGE)
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER FREIBURG·Product code HRS·July 14, 2017
BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4MM, UPPERFACE, (5/PACKAGE)
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER FREIBURG·Product code HRS·July 14, 2017
LAPIPLASTY SYSTEM S4A
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025
ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile, Vol. 2.3ml, REF 220139, Sorenson Medical, Inc., West Jordan, Utah
FDA Recall
Terminated
·Sorenson Medical, Inc.·Product code FRN·October 10, 2006
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 Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·August 1, 2025
Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·January 25, 2023
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·January 25, 2023
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·January 25, 2023