20 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
FDA 510(k)
FDA Class 2
·Radiology
INNOVA 3100-IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017
PureLife+ 2-Ply Dental Bibs
FDA UDI
PURELIFE, LLC·D79010920041·PureLife+ 2-Ply Dental Bibs, White, 2-ply paper...
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252444237·Delta 1.7mm Plate 2x21 holes x 0.5mm
LEONE SPA
FDA UDI
LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZYBIT
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 29, 2021
LINOX SMART SD 60/16
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·May 3, 2013
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·August 27, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 18, 2011
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025
Sunsoft Multiples Toric, methafilcon A, clear contact lens.
FDA Recall
Terminated
·Ocular Sciences, Inc.·Product code LPL·December 9, 2004
BD L-Cath NN (24ga x 30cm), L-Cath Catheter System
FDA Recall
Terminated
·Becton Dickinson Infusion Therapy·Product code LJS·March 9, 2004
BD L-Cath EX (28ga x 20cm), L-Cath Catheter System
FDA Recall
Terminated
·Becton Dickinson Infusion Therapy·Product code LJS·March 9, 2004
BD L-Cath EX (20ga x 15cm), L-Cath Catheter System
FDA Recall
Terminated
·Becton Dickinson Infusion Therapy·Product code LJS·March 9, 2004
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas
FDA Recall
Terminated
·Spinal Concepts, Inc·Product code KWP·April 1, 2002
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
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