17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Orchestrate 3D
FDA 510(k)
FDA Class 2
·Dental
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515025110·Murphy Ret, 7 3/4", 4 prong, sharp
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361442·Integra® Miltex® Bennett Cilia Forceps, 3", 3.2...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746153945·COSMETIC SL EMPOWER CLEAR INTERACT UR CEN 018 T...
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746199820·COSMETIC SL EMPOWER CLEAR INTERACT UR CEN 018 T...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746000119·COSMETIC SL EMPOWER CLEAR INTERACT UR CENTRAL 0...
RELIANCE SPINAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·June 20, 2013
MRIDIUM MRI INFUSION PUMP
FDA Adverse Event
Malfunction
·IRADIMED CORPORATION·Product code FRN·August 4, 2014
VERSYS HIP SYSTEM DISTAL CENTRALIZER
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWL·July 22, 2011
CAPIOX RX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·January 6, 2020
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories, Inc·April 10, 2019
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
Ingenia 1.5T S-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 Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022
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