14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317320681·
PALOMAR SLP 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXSALT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 24, 2014
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013
THREE PEG PATELLA 35MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 17, 2025
40MM/4MM ANCHORING PIN
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·May 14, 2013
RESERVOIR 3ML MMT-332A
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 23, 2014
SERVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·May 26, 2011
INTUITRAK
FDA Adverse Event
Injury
·ENDOLOGIX·Product code MIH·October 28, 2015
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.
FDA Enforcement
Class II
·Terminated·Accuray Incorporated·January 3, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024