12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
FDA 510(k)
FDA Class 1
·Orthopedic
MAXCUT CARBIDE BUR (10/pk) FG 1158
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114371·MAXCUT CARBIDE BUR (10/pk) Shape: Straight Dome...
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032668·microSelectron Coupling Transfer Tube (17)
StaXx® IBL System
FDA UDI
Spine Wave, Inc.·10840642101041·Cartridge Biconvex Expandable Implant 37x18x8mm
SPEEDFIX SUTURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ENTERRA
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LNQ·May 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ARTICUL/EZE BALL 28+8.5 BL
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (DEPUY-SUZHOU) LTD.·Product code JDI·May 13, 2011
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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