47 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PALOMAR LC 100 DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
DUO FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·December 21, 2017
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 31, 2018
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 29, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 13, 2011
XIVE TREPHINE DRILL
FDA Adverse Event
Injury
·DENTSPLY FRIADENT GMBH·Product code DZE·July 25, 2008
ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 25, 2020
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·September 5, 2017
ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·January 11, 2018
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·January 16, 2018
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 7, 2018
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 3, 2017
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·March 19, 2018
ULTRA DUO HIGH FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·December 27, 2017
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·October 9, 2018
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·February 12, 2018