13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WAVi SCAN EEG System and Accessories
FDA 510(k)
FDA Class 2
·Neurology
Probes, Lacrimal
FDA UDI
KATENA PRODUCTS, INC.·00841668114353·LACRIMAL INTUBATION SET (BX/3)
Tensoplast®
FDA UDI
BSN MEDICAL SAS·04042809005561·TENSOPLAST BANDAGE 1" X 5YDS TAN 1
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702827484·ELVAREX 3/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
FDA 510(k)
FDA Class 2
·Cardiovascular
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 7, 2025
INTELLIVUE INFO CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 30, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019