49 results · 26ms · Sources: EU EUDAMED, 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