18 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120213941·Carbide, cone round, universal crown cutter for...
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
FDA 510(k)
FDA Class 2
·Dental
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·August 12, 2024
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 26, 2013
LANX ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·LANX, INC.·Product code KWQ·February 8, 2011
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026
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