34 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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Low Profile Balloon Feeding Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Kirwan
FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019108383·Reusable TPR Bipolar Forceps 7 1/2" (19.1cm) To...
EUROMI EVA SP6
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
FROVA INTUBATING INTRODUCER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code BTR·May 12, 2026
HARMONIC FOCUS
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS·Product code GEI·June 7, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
POLIDENT DENTURE CLEANSER TABLETS
FDA Adverse Event
Death
·BLOCK DRUG CO., INC.·Product code EFT·June 30, 2017
Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. 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
ANATOMIC
FDA Adverse Event
Malfunction
·AMPLITUDE·Product code JWH·December 11, 2018
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