16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VELOFIXTM INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583024370·CH40 ITED, L BE CHARM 40
LINK Instrument
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575415922·Trial Head
LINK Instrument
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575415946·Trial Head
LINK Instrument
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575415939·Trial Head
EKG SPEAKS
FDA 510(k)
FDA Class 2
·Cardiovascular
GEMORE MUSCLE CONDITIONER;
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 24, 2024
LAG SCREWDRIVER GAMMA 3 380 X 110 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code LXH·June 14, 2012
SYNERGY BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·October 1, 2014
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·May 29, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 17, 2011
IMMULITE 2000 ESTRADIOL
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024
IMMULITE 2000 ESTRADIOL
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024
IMMULITE 2000 ESTRADIOL
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015