21 results
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19ms
·
Sources: EU EUDAMED, US FDA
Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
FDA 510(k)
FDA Class 2
·Anesthesiology
OSE
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042122468·Super Elastic Nickel Titanium Archwires Natural...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776409081·NEIDRE ELEVATOR 10.5" DE WOODSON & DISSECTOR
MORRISON MEDICAL
FDA UDI
MORRISON MEDICAL, LTD·00647921251021·CORR.PLAS.SPLNT.PLAIN 18"25/CS
Life Instruments
FDA UDI
Life Instrument Corporation·M930725102520·Impactor 90 deg.
Life Instruments
FDA UDI
Life Instrument Corporation·M930725102500·Neidre Elevator (Woodson/Dissector) Dbl End
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251025400·ceraMotion® Ti Base Dentin A4, 40 g / dental ce...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251025200·ceraMotion® Ti Base Dentin A4, 20 g / dental ce...
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555287251025·ø7.2 Triple Lead Reduction Screw Assembly, 25mm
iHearTest
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Exactech, Inc.·10885862523808·TRIAL, TIBIAL BASEPLATE, SIZE 2.5T
Fuchsin Basic boja u prahu, C.I. 42510, 25 g
Device
EU IVDR
·
Eu Ivd Class A
·BioGnost Ltd.·On the market·32 countries
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 11, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·November 11, 2015
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 14, 2014
MINI-CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 16, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 29, 2013
DEVILBISS
FDA Adverse Event
Malfunction
·DEVILBISS HEALTHCARE LLC·Product code CAW·August 24, 2018
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024