11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
FDA 510(k)
FDA Class 1
·Dental
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JDI·January 8, 2014
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 24, 2014
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·May 24, 2011
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025