22 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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CROSSLEAD Tracker
FDA 510(k)
FDA Class 2
·Cardiovascular
JEDMED
FDA UDI
JEDMED INSTRUMENT COMPANY·M6332415100·FORCEPS JEWELERS-TYPE #3C SEMI-DISP
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776295905·Greenburg Long Flex Retractor
X SERIES
FDA UDI
Zoll Medical Corporation·00847946005771·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946018924·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946006358·Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946012175·Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946062477·X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEA...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946019396·Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W...
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
FDA 510(k)
FDA Class 1
·General Hospital
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
X SERIES
FDA UDI
Zoll Medical Corporation·00847946029944·X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEA...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946012182·Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946062484·X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEA...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946018252·Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W...
LUMAX 340 HF-T
FDA Adverse Event
Injury
·BIOTRONIK, GMBH AND CO.·Product code LWS·November 20, 2008
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 9, 2011
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·July 22, 2013
VERSA-DIAL 42X18X46 HUM HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·June 7, 2023
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 13, 2022