10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALEO PEDICLE SCREW SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACE BIO WIN TIBIAL NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UF BRACHYTHERAPY STAND
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN DEPUY ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC./REG. #1818910·Product code KWA·April 23, 2013
SYBRONPRO TL
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·May 1, 2011
IDENTITY ADX DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008
MDLR CNLTD TRIDRV DRVR
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·August 29, 2023
Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024