13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
FDA 510(k)
FDA Class 1
·General Hospital
Sonic
FDA UDI
Sbo Hearing A/S·05714464052448·RADIANT 40 FW 1.3.0
Reddick Cholangiogram Catheter
FDA UDI
Lemaitre Vascular, Inc.·00840663101702·Reddick Cholangiogram Stiffer Catheter, 4F, eIFU
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00841785113406·
Trial BiPolar Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215045562·
KJ EXTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MEGVISION, MODEL EQ1000C SERIES
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 9, 2011
SWEET PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 22, 2013
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code DQO·February 7, 2017
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017