28 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VAULT ALIF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776172480·Cushing Dressing Forceps serrated
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169604841·SPACER 2130445 OLIF25 27MM 0 DEG 14X45
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180937·Integra® Jarit® Cushing Dressing Forceps, 7-3/4...
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925018761·MCGEE ROUND PICK, SMALL
POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KLASSIC HD HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·June 16, 2011
GORE VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·August 19, 2008
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
STOPCOCK MANIFOLD GANGS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·October 30, 2017
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 9, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·February 28, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 8, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·April 25, 2018
MBB Tray Catalog Number: 9882
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013