11 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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GN OTOMETRICS TYPE 1053 FREEFIT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IFS PROFILE PLATES, SCREWS, AND WASHERS
FDA 510(k)
FDA Class 2
·Orthopedic
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
FDA 510(k)
FDA Class 2
·Anesthesiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 1, 2023
ACCU-CHEK RAPID-D LINK INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·May 20, 2011
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code MND·September 12, 2014
POLYETHYLENE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·April 5, 2022
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2015
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025