9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NON-STICK ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ebony PTA 0.035 Peripheral Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
LUMAX 340 HF-T
FDA Adverse Event
Malfunction
·BIOTRONIK BMBH AND CO.·Product code MRM·November 20, 2008
NELLCOR OXIMAX N-65
FDA Adverse Event
Malfunction
·SANMINA - SCI SYSTEMS·Product code DQA·July 18, 2013
LAPIPLASTY 4.0MM FULLY THREADED SCREW
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025
SONICONE®O.R. SONICVAC
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·December 2, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025