17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120708·LATERAL,SPACER 22,45X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120722·LATERAL,SPACER 22,55X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120739·LATERAL,SPACER 22,60X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120746·LATERAL,SPACER 22,65X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120692·LATERAL,SPACER 22,40X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120715·LATERAL,SPACER 22,50X7.5,0 DEG
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
FDA 510(k)
FDA Class 2
·Anesthesiology
ANESTHESIA CONDUCTION NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 4, 2008
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·July 18, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021