17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATLANTIS Conus Structure
FDA 510(k)
FDA Class 2
·Dental
SYNTEC DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 29, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 7, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·July 21, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 30, 2008
GORE PROPATEN VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·September 17, 2019
GORE VIABAHN ENDOPROSTHESIS - 3
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code PFV·September 17, 2019
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 27, 2013
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 21, 2020
ENSEAL G2 SUPER JAW
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·September 21, 2020
AXIUM
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·December 9, 2024
TRUE METRIX
FDA Adverse Event
Injury
·TRIVIDIA HEALTH INC·Product code NBW·August 13, 2024
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·March 23, 2018
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012