15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ApolloKnee
FDA 510(k)
FDA Class 2
·Neurology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111149740·SKLARLITE METZ LAHEY STR 4.5"
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021291·INTRG WHISP ROTH 2BIC HK-22T 0A 022 LL
Rx Knee Femoral Universal Augment Trial Size Medium
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215122546·
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
SPIRIT III TOTALSENSE CARDIAC COIL
FDA 510(k)
FDA Class 2
·Radiology
CFP-3131, CFP-2222
FDA 510(k)
FDA Class 2
·Radiology
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·February 3, 2025
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
ENTERALITE INFINITY
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP (ZEVEX)·Product code LZH·June 20, 2013
SURGICAL TROCAR STABILITY SLEEVES- 5MM DIAMETER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GCJ·November 10, 2008
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH. LTD. / HUNTINGTON·Product code MFK·August 26, 2011
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·May 6, 2020
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Enforcement
Class I
·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022