14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517576415·CoRoent Ant TLIF Ti, 9x12x40mm 0°
Midmark
FDA UDI
MIDMARK CORPORATION·00841709122194·Track and Trolley Assembly used for Track Mount...
BAK®
FDA UDI
ZIMMER SPINE, INC.·00889024333352·
BP® Lordotic
FDA UDI
ZIMMER SPINE, INC.·00889024338593·
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYPHILIS HEALTH CHECK
FDA 510(k)
FDA Class 2
·Microbiology
LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X320MM X 125°
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HSB·January 28, 2025
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
FDA Adverse Event
Malfunction
·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Injury
·ZOLL MANUFACTURING CORPORATION·Product code MVK·April 3, 2025
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 15, 2008
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC.·Product code CBK·June 18, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
INVACARE·Product code CAW·August 5, 2011
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018