14 results
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26ms
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Sources: EU EUDAMED, US FDA
AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPEEDPASS DISPOSABLE
FDA UDI
Biomet Orthopedics, LLC·05019279058679·
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746099939·DB BKT MASTER 6.0MM FLAT LANG UL LAT 018 T+8 A+...
Symmetry Surgical®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482142301·FlashPak® Mat, Silicone Pin Mat, For 9040-08
RYDERS
FDA UDI
FGX INTERNATIONAL INC.·00772956428602·
VARICOSCREEN(TM)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCESS 2I (LXI) IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHA·November 20, 2010
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 9, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024