12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASAHI CROSSWALK Peripheral Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
AccuQuest
FDA UDI
Bernafon AG·05711584088685·AQ CO3 MNR T, 2.4G NFM DPB SABE/MSIL ACCUQ
INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
FDA 510(k)
FDA Class 2
·General Hospital
MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
MONOCRYL PLUS ANTIBACTERIAL SUTURES
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAN·October 8, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2013
CAP FOR INJECTOR MEMBRANE M50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·May 4, 2021
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022
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
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018