16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111211256·PEAN FORCEP 5 1/2"
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045889·PrimaLIF LLIF PEEK Implant, 17mm X 26mm X 55mm,...
AIDI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
FALCK APPLANATION TONOMETER (FAT2)
FDA 510(k)
FDA Class 2
·Ophthalmic
BD 10ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 5, 2020
ACCU-CHEK ® ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 22, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·June 17, 2013
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019
BD 10ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 14, 2020
TRULIANT TIB IMP PS INSERT SZ 4 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 4, 2025
PEDICLE SCREW 6X45
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019
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
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021