17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...
TULSA-PRO
FDA UDI
Profound Medical Inc·07540281001721·TULSA-PRO DISPOSABLE KIT
4285 SLIDE VLV CONTROL
FDA UDI
HANS RUDOLPH, INC.·00874750009046·4285A 1 SLIDE VLV CNTRL 115V
INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TIBIAL NAIL, STANDARD T2 TIBIA 9X300 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 12, 2012
TELAMON FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012
COULTER® LH 750 HEMATOLOGY ANALYXZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 14, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 10, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 26, 2011
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025