10 results · 20ms · Sources: EU EUDAMED, 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