17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CoLink Cfx Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083875·METZENBAUM SCISSORS CVURED TENOTOMY TIP POWER C...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154681631·L-PLATE, 90DEGREE, 6MM BAR, LEFT, STANDARD
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
GATIFLOXIN
FDA 510(k)
FDA Class 2
·Microbiology
APPLIED MEDICAL STENT EXTRAFLOW STENT
FDA Adverse Event
Injury
·APPLIED MEDICAL·Product code FAD·December 11, 2007
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code DTK·January 17, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·July 27, 2011
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·July 1, 2013
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DTK·January 16, 2013
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code DTK·January 17, 2013
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021