16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
ForPro
FDA UDI
Tng Worldwide, Inc.·00672047000239·Vinyl Exam Gloves
Size Large
100ct
SSW CARBIDE
FDA UDI
Ss White Burs, Inc.·D6901407352·FG SL CARBIDE 703 - 5 PACK
Cancellous Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120034307874·Cancellous Screw, Cannulated, D=4.0mm, L=35m
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046312·PrimaLIF LLIF PEEK Implant, 7mm X 26mm X 35mm, ...
SYRINGE 0.5ML 29GA 1/2IN BLS 100BX AU
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 12, 2020
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
COBAS 6000 C (501) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 18, 2016
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·May 31, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·June 15, 2011
BREEZE2
FDA Adverse Event
Injury
·BAYER HEALTHCARE LLC·Product code NBW·October 3, 2014
UNID ROD
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024
UNID ROD
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
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