24 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FotoDent denture
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003319·Diagnostic EP Catheter, Cournand curve, 4 elect...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016148·Modular Cannula, Long Pointed
ELMED
FDA UDI
ELMED INCORPORATED·00842180102996·BIPOLAR RF-CABLE FOR ELMED TRIPLE FUNCTION FORC...
WalkAide
FDA UDI
INNOVATIVE NEUROTRONICS, INC.·00858184006451·WalkAide Oval Velcro Electrode, 1.5" x 3.25"
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
FDA 510(k)
FDA Class 2
·Dental
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·May 27, 2024
DREAMSTATION 2 ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 3, 2025
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 8, 2024
BOOMERANG
FDA Adverse Event
Injury
·CARDIVA MEDICAL, INC.·Product code MGB·November 6, 2007
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·July 30, 2024
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 17, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013
PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 18, 2019
ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 18, 2019
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·August 19, 2019
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·August 18, 2019
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 19, 2019