28 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040054670·Polycarbonate Crowns
Scanlan® SURG-I-BAND® color coding
FDA UDI
SCANLAN INTERNATIONAL INC·00846159001594·Scanlan® SURG-I-BAND® color coding - Labels-Sol...
Health-Tec/DHP Hand Instruments
FDA UDI
Dental Health Products Inc·D7737001804·Health-Tec/DHP College Pliers Self-Locking Serr...
Propel
FDA UDI
PROPEL ORTHODONTICS LLC·00852673007080·C-Shaped Vibration Device, Brazil
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967188294·Battalion, LLIF Trial, 0°, 18 mm Wide, 04 mm X ...
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180509968·LLIF DISTRACTOR PARTIAL RASP, 1/4" SQ., 18MM X ...
Intervertebral Disc Preparation Instruments
FDA UDI
ALPHATEC SPINE, INC.·00190376381107·LIF, BROACH, CC OFFSET, 18MM X 04MM
Intervertebral Disc Preparation Instruments
FDA UDI
ALPHATEC SPINE, INC.·00190376380711·LIF, BROACH, STRAIGHT, 18MM X 04MM
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376647067·BROACH, LIF NAV, STRAIGHT, 18MM X 04MM
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·March 13, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 3, 2011
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·February 19, 2008
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 14, 2023
PICC-NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 23, 2014