34 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hang&Go PAC
FDA 510(k)
FDA Class 2
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00842528102169·5.5 mm Cannulated Tap, Standard AO Quick Release
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
FDA 510(k)
FDA Class 2
·Hematology
XELIS FUSION
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code BTR·May 12, 2026
ENTRUST
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 14, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·June 11, 2013
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code BTR·February 8, 2024
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code BTR·January 3, 2020
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code BTR·April 28, 2022
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code BTR·September 27, 2024
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code BTR·August 29, 2023
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code BTR·August 31, 2023
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code BTR·October 15, 2021
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code BTR·May 1, 2020
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code BTR·January 3, 2019