Device Directory
Browse 5,064 FDA-cleared medical devices
DeepRhythmAI (K253141)
Class Class II K253141 DQK
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista (K252897)
Class Class II K252897 HRS
KLS Martin Pure Pectus System (K250988)
Class Class II K250988 HRS
Revi System (K252391)
Class Class II K252391 QXM
iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (K251092)
Class Class II K251092 SCA
TRAUMAGEL® 2.0 Hemostatic Gel (K253609)
Class Class U K253609 QSY
TopCEM Vigor SA Self-Adhesive Resin Cement (K252785)
Class Class II K252785 EMA
Cerynë Intimate Care (K250488)
Class Class II K250488 NUC
EnCor EnCompass™ Breast Biopsy and Tissue Removal System (K252681)
Class Class II K252681 KNW
VizMark Preloaded Tissue Marker Device (VM-0001) (K251989)
Class Class II K251989 NEU
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