16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
FDA 510(k)
FDA Class 2
·Ophthalmic
Depth gauge
FDA UDI
Jeil Medical Corporation·08806390880695·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089402779·
EXHALE RF PROBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PREMIO 10 MOXA
FDA 510(k)
FDA Class 2
·Physical Medicine
LINEAR? ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 11, 2026
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·May 8, 2013
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 18, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 1, 2015
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·November 15, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·December 23, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·December 4, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025