13 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ruby XL System
FDA 510(k)
FDA Class 2
·Cardiovascular
MDx-Chex for BC-GP
FDA UDI
STRECK, INC.·00844509002468·MDx-Chex™ for BC-GP is intended for use as an e...
Femoral Head Extractor Long
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215037970·
Corkscrew Head Extractor - Long
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057909·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161122500790·Femoral Head Extractor Long
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
FDA 510(k)
FDA Class 2
·Dental
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·March 2, 2022
MP20 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Death
·AGILENT TECHNOLOGIES DEUTSCHLAND·Product code MHX·November 7, 2014
ENDO GIA II 60-3.5 SULU
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·September 9, 2011
MIDLINE CATHETERIZATION SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LJS·July 24, 2013
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013