14 results
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24ms
·
Sources: EU EUDAMED, US FDA
GLOOKO LOGBOOK CHARTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Z Liquid HT A1-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818122142·Dental porcelain/ceramic restoration kit
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973097·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971215·
CRAWFORD BIOCANALICULUS INTUBATION
FDA 510(k)
FDA Unclassified
·Unknown
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2017
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·June 28, 2010
APEX KNEE SYSTEM
FDA Adverse Event
Injury
·OMNLIFE SCIENCE, INC.·Product code JWH·May 17, 2013
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 11, 2010
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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