8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDINAUT Kyphoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
MENTOR ARIS SUPRAPUBIC SURGICAL KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 27, 2024
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 8, 2013
MEMBRAGEL
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code NPK·June 30, 2011
LCS COMPLETE M/B PAT CEM STD
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·September 4, 2008
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014