19 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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M.U.S.T. EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip Catheter
FDA UDI
Unisensor AG·07640172971406·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482000298·Symmetry® Guide, Guard, Large
RECAP/MAGNUM HIP INSTRUMENTATION
FDA UDI
Biomet Uk Ltd·05019279108183·
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA 510(k)
FDA Class 2
·Anesthesiology
RETRIEVE IMPLANT CEMENT
FDA 510(k)
FDA Class 2
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523106356·Porous Acetabular Cup System - Hemispherical Sh...
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569515·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569539·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638105·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569522·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638099·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638082·
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·July 6, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYS INC.·Product code LZG·June 16, 2011
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·August 27, 2008
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014