13 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARENA-C
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613097523·Farrior Round Ear Speculum, Regular End, Size 3...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613097530·Farrior Round Ear Speculum, Regular End, Size 4...
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PRO WALKER ML-300 FOLDABLE WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
DEVICE T165/141337 IMPLANTED 07-MAR-2008
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·November 10, 2009
AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·October 3, 2014
CAPSUREFIX
FDA Adverse Event
Death
·MPRI·Product code DTB·June 3, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 27, 2011
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025