15 results
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22ms
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Sources: EU EUDAMED, US FDA
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NM3 Monitor, French
FDA UDI
Respironics Novametrix, LLC·00884838015630·
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70604581·Mini-Mono-Brackets Alexander 'S' .022" 200 Brac...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0604500·Tray, Base, 4.5"
THE MAESTRO SYSTEM
FDA 510(k)
FDA Class 2
·Dental
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PROFEMUR(R) HIP STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010
PURACOL PLUS COLLAGEN WOUND DRESSING
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code KGN·April 16, 2026
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 25, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·June 13, 2008
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011
PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.
FDA Recall
Terminated
·Respironics Novametrix, LLC.·Product code BZK·July 29, 2011
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022