13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TenoTac Soft Tissue Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428644706·A hand-held battery-powered electronic instrume...
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707184438·Accufit Molar Bands Lower Right Second Molar 38...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114117·SIMCOE CORTEX EXTR 23GA 0.4MM TXT PK/10
SECURVIEW DX DIAGNOSTIC WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
TWILITE, TWILITE WHITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRN ADAPTER
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FMG·February 6, 2026
VITROS CHEMISTRY PRODUCTS PHYT SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·October 10, 2008
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 2, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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