14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
INBONE
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420196620·Revision Poly Gauge
Intraoral Scan Body WP
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059075175·
McCABE FACIAL NERVE DISSECTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060906·McCABE FACIAL NERVE DISSECTOR ANGLED SMOOTH TIPS
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964082559·Trial Procedure Kit
INTERVENTIONAL BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
CLASSIC TENS
FDA 510(k)
FDA Class 2
·Neurology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·November 21, 2023
VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·October 24, 2014
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FSA·July 1, 2013
EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·October 15, 2004
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·January 13, 2015
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