13 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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MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964111327·Custom Procedure Kit
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 27, 2023
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
FDA 510(k)
FDA Class 2
·Microbiology
NEOLEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
ANTI-A (MURINE MONOCLONAL) SERIES 1
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·November 3, 2006
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 14, 2013
DELTA CER HEAD 12/14 32MM +1
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code LZO·May 13, 2011
SYCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 13, 2008
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 25, 2015
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 L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025