9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDODONTIC ROOT CANAL PLUGGER FINGER-
FDA 510(k)
FDA Class 1
·Dental
AmFab Co., LLC
FDA registration
AmFab Co., LLC·1 product·🇺🇸 United States
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OSSEOFUSE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014
ALIGN URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·November 9, 2012
ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·January 15, 2008
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015