13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CROSSLEAD Penetration Peripheral Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
Cyto-Chex® BCT
FDA UDI
STRECK, INC.·40844509000837·A direct-draw blood collection tube for the pre...
EarQ
FDA UDI
Sbo Hearing A/S·05714464030552·EARQ F30 MINIRITE T C094
VERSANT ATTITUDES
FDA UDI
FGX INTERNATIONAL INC.·00193033307977·
Neroma Gelpi Spinal Retractor
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896120839·Neroma Gelpi Spinal Retractor With Speed Lock B...
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
IAB : 8 FR - 30 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·November 7, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 16, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025