10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AngioSculpt PTA Scoring Baloon Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171027973·PESSARY, CUP #3, W/SUPPORT, 65/33mm
MODIFICATION TO: ARTHREX V-TAK
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES MATRIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTO INFLATE RCSP
FDA Adverse Event
Injury
·PERFUSION SYSTEMS·Product code DWF·January 5, 2018
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 6, 2013
ECHELON 60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 6, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013
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