11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Comatryx OTC
FDA 510(k)
FDA Unclassified
·Unknown
HQ-Chex
FDA UDI
STRECK, INC.·00844509001737·A whole blood glucose and hemoglobin control de...
DIGITAL ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
Nd: YAG Laser Therapy Systems HM-YL900
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 14, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MED CORP·Product code MKJ·July 19, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 18, 2013
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·March 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·March 4, 2020
EXODONTIA ELEVR #46R SERRATED
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code EMJ·August 12, 2025
EXODONTIA ELEVR #46R SERRATED
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code EMJ·August 12, 2025