12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD HYPOINT NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Silicone Flat Drain
FDA UDI
C. R. Bard, Inc.·00801741090769·Hubless Silicone Flat Drain, 10mm Wide (3/8" ap...
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481475289·
HARDYDISK CEFTRIAXONE 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
FREELITE LAMBDA FREE KIT
FDA 510(k)
FDA Class 2
·Immunology
PULSE GEN MODEL 102
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·February 29, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·April 27, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·July 1, 2008
SILICONE FLAT DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 20, 2025
HUBLESS SILICONE FLAT DRAIN
FDA Adverse Event
Injury
·PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590·Product code GBX·March 30, 2017
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024