20 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
Xiros
FDA UDI
Provision·B50SR420214130·
CC-Hook Right
FDA UDI
XIROS LTD·05060267131362·
CC-Hook Right
FDA UDI
XIROS LTD·05060267134028·
POWDER-FREE VINYL EXAM GLOVE, YELLOW
FDA 510(k)
FDA Class 1
·General Hospital
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
FDA 510(k)
FDA Class 3
·Cardiovascular
M-H HA/PC 11X160MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 16, 2015
M-H SOLID SHELL HA/PC DIA54MM LN24
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·March 1, 2016
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·August 27, 2024
MALLORY-HEAD SHORT FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MEH·July 28, 2017
MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MEH·August 11, 2016
CORAIL2 LAT COXA VARA SIZE 11
FDA Adverse Event
Malfunction
·DEPUY FRANCE·Product code LZO·March 26, 2013
INTEGRIS ALLURA 15-12 (MONO)
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·February 8, 2011
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007
MLRY-HD XR LAT POR FMRL 8MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 24, 2020
UNK LINX MAGNETIC IMPLANT
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·July 7, 2023
M-H HA/PC 12X165MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 16, 2015
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017