25 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CHAD THERAPEUTICS OXYMATIC MODEL 401
FDA 510(k)
FDA Class 2
·Anesthesiology
Preat
FDA UDI
Preat Corporation·00842092183847·ASC NobelActive?/Conical-compatible NP X 9mm En...
Preclean Kit
FDA UDI
MEDIVATORS INC.·40677964007604·Preclean Plus Kit includes DEFENDO Air/Water Su...
Truliant
FDA UDI
Exactech, Inc.·10885862623706·Special Truliant DF FFG Uncaptured Anterior and...
FlowLogic Assert
FDA UDI
SONENDO, INC.·00810209421342·FlowLogic Assert Shaping File Variable Kit, 21mm
TRUSTEEL
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·August 22, 2024
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TISSUE LEVEL DENTAL IMPLANT RP Ø3.3 L10
FDA Adverse Event
Injury
·HAGER & MEISINGER GMBH·Product code DZE·September 27, 2023
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 9, 2024
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 11, 2024
NA
FDA UDI
Zimmer, Inc.·00889024024441·
NA
FDA UDI
Zimmer, Inc.·00889024024458·
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·February 24, 2011
ARCHITECT C8000
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·February 21, 2008
ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL
FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016
C8XX2, GELPORT 120MM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·April 11, 2022
C8XX2, GELPORT 120MM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·April 7, 2022
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
FDA Enforcement
Class II
·Terminated·PTW-Freiburg·September 2, 2015