10 results
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32ms
·
Sources: EU EUDAMED, US FDA
EndoFLIP® System with FLIP Topography module
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SILICONE MCP
FDA UDI
Stryker GmbH·00886385021942·Broach, Size 50
SYLE SMARTIP
FDA 510(k)
FDA Class 1
·Dental
ATLANTIS ABUTMENT FOR ASTRA IMPLANT
FDA 510(k)
FDA Class 2
·Dental
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·June 18, 2020
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014
LIGASURE PRECISE+
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·June 7, 2013
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 22, 2011
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.
FDA Enforcement
Class II
·Ongoing·ConvaTec, Inc·March 27, 2019
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024