18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DYNA-EXTOR II
FDA 510(k)
FDA Class 2
·Orthopedic
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
CEROS TCP GRANULES
FDA 510(k)
FDA Class 2
·Dental
SUCTION HANDLE AND COAGULATOR
FDA Adverse Event
Malfunction
·CAMERON-MILLER, INC.·Product code GEI·November 18, 2024
SUCTION HANDLE AND COAGULATOR
FDA Adverse Event
Malfunction
·CAMERON-MILLER, INC.·Product code GEI·November 18, 2024
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·June 6, 2023
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
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 20, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 25, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·October 14, 2019
TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·October 3, 2019
TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·October 15, 2019
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
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