20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RADIFORCE LARGE MONITOR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605343·SPACER 2112645 OLIF25 20MM 12 DEG 18X45
2810 3WAY SLIDE VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750009336·2810C 3W SLDVL 1.375OD/1.125ID
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741126450·
Algovita®
FDA UDI
Greatbatch Ltd·00821329580222·Algovita® 12 Electrode Percutaneous Lead Kit - ...
Velocity™ Expandable Interbody System
FDA UDI
Spine Wave, Inc.·10840642106916·Expandable Implant, 25(L) X 10(W) X 8-14(H) 8 D...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674112645060·
WILLOW/ELM PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
REPROCESSED EBI EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 15, 2026
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 20, 2025
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 19, 2011
PROXIMATE RELOADABLE LINEAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2008
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
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