11 results
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26ms
·
Sources: EU EUDAMED, US FDA
PERI-GUARD PERICARDIAL PATCH-HERNIA
FDA 510(k)
FDA Class 2
·Cardiovascular
IRRIGATION BAG SPIKE, TUBING CONNECTOR
FDA UDI
W.H. Holden, Inc.·D9288330210·
NTI
FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E310833021FFG1·NTI Diamond Fine FG
MIXING SYRINGE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
FDA 510(k)
FDA Class 2
·Cardiovascular
OPTIFLUX 160NRE DIALYZER FINISHED ASY
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·March 25, 2014
7.3MM CANNULATED SCREW 32MM THREAD/100MM
FDA Adverse Event
Malfunction
·Product code HWC·November 1, 2012
INBONE POLY
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·July 1, 2010
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code KNT·June 12, 2024
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018