12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
HP M2600A VIRIDIA TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
artegral life
FDA UDI
Merz Dental GmbH·D7091993516·anteriors; shade D4; mould UCS
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198345·AK3 PS Insert Trial Size 5, 16mm
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAPIOX HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016
MUSTANG PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·March 7, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 8, 2014
SEGURA HEMISPHERE STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FFL·February 16, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025