11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile Powder Free Patient Examination Gloves, Blue Color
FDA 510(k)
FDA Class 1
·General Hospital
Sklar
FDA UDI
SKLAR CORPORATION·30649111360774·DRESS. JAR 3 QT W/COVER PK 12
DIGITAL ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
MED GRAVITY SET, IMED PUMP SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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