25 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIRWAY BALLOON CATHETER INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
FDA 510(k)
FDA Class 2
·General Hospital
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
FDA 510(k)
FDA Class 2
·Cardiovascular
RTE SNAPCONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023
REAR TIP EXTENDER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025
RTE SNAPCONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021
BIOLOX DELTA CER LNR 36MM E
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LZO·February 5, 2026
RINGLOC-X E1 H/W 56/36MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·April 27, 2026
BIOLOX DELTA CER LNR 40MM G
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·April 27, 2026
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 2, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 15, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 19, 2011
AVAN E1 INSERT 28 S 52
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 6, 2025
BIOLOX DELTA CER LNR 32MM E
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·September 8, 2025
RINGLOC BIPOLAR VIVACIT-E
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·September 10, 2025
BIOLOX DELTA CER LNR 36MM E
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·November 13, 2025
BIOLOX DELTA LNR 40MM 58-60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·August 21, 2025
BIOLOX DELTA LNR 36MM 62-70MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 20, 2024
BIOLOX DELTA CER LNR 36MM E
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·May 22, 2025
BIOLOX DELTA CER LNR 36MM E
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LPH·March 28, 2025