23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROCRUISER PLUS INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040011973·Zirlux 16+ 0M3 95X18
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450201077·
INSET GUARD
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·October 29, 2025
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033355381·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033355367·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033355398·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033355350·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033355343·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033355374·
CORTISOL LIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.
FDA Enforcement
Class II
·Terminated·Physio Control, Inc.·July 31, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·March 19, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·February 9, 2011
*
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·February 12, 2008
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·September 6, 2024
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.
FDA Enforcement
Class II
·Terminated·Physio-Control, Inc.·April 8, 2020
biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code MKT·June 13, 2007
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018