15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ERTAPENEM 10UG BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
Safco NiTi RL Rotary Files
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310208423·Safco NiTi RL rotary files, #60, (0.4 taper / 2...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093790·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR2 8T/9...
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062772·Mini Uni-Twin(TM) Bracket APC(TM) II UR2 8T/9A ...
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 25, 2010
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ NORTH AMERICA, INC.·Product code LNM·October 29, 2014
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 27, 2024
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT·Product code CBK·March 18, 2013
FLOW CYTOMETERY (FC500) TETRACXP SYSTEM FOR THE CYTOMICS FC 500
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·March 16, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020