34 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
FDA 510(k)
FDA Class 2
·Ophthalmic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030027·WONDER MODEL 70, SIZE XL, GLACE, GRADUATED COMP...
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037308974·CUTTING GUIDE HOLDER
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776289256·Bunnell Tendon Stripper,
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar
NA
FDA UDI
STRYKER CORPORATION·34546540756504·1.0MM X 14IN NITINOL GUIDE WIRE
Stryker
FDA UDI
Provision·B504OM2340300270·
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND HIP ARTICULATION
MAXIM KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INSUFFLATION NEEDLE, MODEL R65-933
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ZEPHIR® ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND ARTICULATION SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND ARTICULATION SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·Ceramic Transcend® Hip Articulation System
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND ARTICULATION SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND HIP ARTICULATION
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND ARTICULATION SYSTEM