9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INCISION & DRAINAGE TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Brigade
FDA UDI
Nuvasive, Inc.·00887517672247·Brigade Trial, 21x34x36mm, 8°
GC E-LIGHT
FDA 510(k)
FDA Class 2
·Dental
TRUCLEAR OPERATIVE HYSTEROSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
3.5MM LCP CLAVICLE HOOK PL 6H 18MM HOOK DEPTH/73MM/RT-STER
FDA Adverse Event
Injury
·SYNTHES RARON·Product code HRS·September 22, 2015
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
2.7MM TI LCP ULNA OSTEOTOMY PLATE/6 HOLES-STERILE
FDA Adverse Event
Injury
·SYNTHES RARON·Product code HRS·June 2, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024