13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASAP OTC WOUND DRESSING GEL
FDA 510(k)
FDA Unclassified
·Unknown
Fuji Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711404831·83mm Level 4 Cervical Plate System - Fuji
MODIFIED HD GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUESTRA FLUID DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX LLC·Product code FPA·October 30, 2017
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·May 31, 2013
SURGISCREEN
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KSZ·June 12, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015