17 results · 23ms · Sources: EU EUDAMED, 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