10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HANAROSTENT LowAx Colon/Rectum (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029041642·Non-Extraction w/Seating Springs
PRONTOSAN ANTIMICROBIAL WOUND GEL
FDA 510(k)
FDA Unclassified
·Unknown
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 19, 2016
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 26, 2013
CLARION IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·September 18, 2014
HS FOCUS 17 CM CURVED SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 4, 2011
RETENTION PIN SHORT XL25
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·September 16, 2024
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019