14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NeuroAmp II, NeuroAmp II.5s
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 14, 2022
PR CREAM
FDA 510(k)
FDA Unclassified
·Unknown
CARDIO MED MODEL A102, H104, O101, P103, AND Z100
FDA 510(k)
FDA Class 2
·Cardiovascular
NEXTAR INFRARED CAMERA
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2024
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 7, 2008
SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code HWC·June 25, 2013
CANE, CRUTCH AND WALKER TIPS AND PADS
FDA Adverse Event
Malfunction
·UNKNOWN·Product code INP·August 5, 2011
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
THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·August 13, 2024
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·February 28, 2012
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·November 21, 2025
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016