28 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VASCUTRAK PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 30, 2018
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION OF NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973257·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973301·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970041·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970065·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970126·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971185·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970058·
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·December 4, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2025
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·May 9, 2013
BELT CLIP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·September 19, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 26, 2011
MICRUSFRAME10 4MM X 11.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2021
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 10, 2021
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·December 26, 2018