11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
NEXT Extra Coarse Mint Prophy Paste Box 200
FDA UDI
Preventech·D024220043·NEXT Extra Coarse Mint Prophy Paste Box of 200 ...
Suture Shuttle Straight - Green
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215164867·
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029912·Bipolar Head Assembly, Size 43mm
UNK HEALING ABUTMENT
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NHA·November 22, 2019
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B
FDA 510(k)
FDA Class 2
·Orthopedic
CSM INTERNAL-R IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 31, 2008
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 12, 2011
FORTIFY DR, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023