13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LARS AC Band Device
FDA 510(k)
FDA Class 2
·Orthopedic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804106·Marina Splinter Forceps, 10cm
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029041666·Non-Extraction w/Seating Springs
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 21, 2002
HET BIPOLAR ELECTROCAUTERY FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILOT DIODE LASER, MODEL 002-00139
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VSP SYSTEM
FDA Adverse Event
Injury
·3D SYSTEMS·Product code DZJ·December 18, 2020
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 26, 2013
SARA 3000
FDA Adverse Event
Injury
·MEDIBO N.V.·Product code FSA·May 27, 2008
COOL LINE
FDA Adverse Event
Malfunction
·ALSIUS CORPORATION·Product code NCX·September 26, 2008
SYNCHRO2-14 SUPPORT STRAIGHT 215CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023
MENTOR SILTEX ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 15, 2018
SenTec Membrane Changer Insert [5 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