19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
FDA 510(k)
FDA Class 2
·Radiology
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331089·Nail cap for Fixion interlocking intramedullary...
KANEDA SR
FDA UDI
Medos International Sàrl·10705034005294·KANEDA SR ANTERIOR SYSTEM INSTRUMENT HANDLE (MO...
LEONE SPA
FDA UDI
LEONE SPA·08033707080879·HARD WIRE CUTTER CLASSIX
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702421057·E3/AG/SL-OT/TC-WOV/BR
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522109000·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16721312109000·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702388398·ELVAREX FORTE 3/THIGH HIGH/SLANT, OPEN TOE, E-V...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702885972·ELVAREX 1/THIGH HIGH/SLANT-CLOSED TOE/DOTTED SI...
STS-T LITHOTRIPTER, MODEL STS-T
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE THYROID COLLAR
FDA 510(k)
FDA Class 1
·Radiology
INTELLIVUE INFO CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024
MEDSTONE LITHOTRIPTOR
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
DLP SILICONE RCSP RETROGRADE RETROGRADE RETROGRADE CANNULA
FDA Adverse Event
Injury
·PERFUSION SYSTEMS·Product code DWF·December 9, 2020
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·November 16, 2022