14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA SPHERICAL AMALGAM ALLOY
FDA 510(k)
FDA Class 2
·Dental
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123175·K-WIRE - SINGLE TROCAR THREADED 1.8mm DIA x 150mm
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
FDA 510(k)
FDA Class 2
·General Hospital
PremiPatch PTFE Pledget
FDA 510(k)
FDA Class 2
·Cardiovascular
URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FGB·December 16, 2016
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013
PUMP MMT-722LNAP PRDGM INS PL EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·December 30, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·UNKNOWN·Product code CAW·July 23, 2014
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
UNKNOWN
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025