17 results · 20ms · Sources: EU EUDAMED, 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