14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SOFRELINER TOUGH S
FDA 510(k)
FDA Class 2
·Dental
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605244·SPACER 2112445 OLIF25 20MM 12 DEG 14X45
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741124450·
Algovita®
FDA UDI
Greatbatch Ltd·00821329580185·Algovita® 12 Electrode Percutaneous Lead Kit - ...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674112445060·
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
M2A-T M/H RAD 2HL SHL 41/56MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 14, 2013
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·April 28, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
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