Search FDA 510(k) Database

6,920 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
17377–17400 of 174,061
Cleared Sep 11, 2020
DePuy PINNACLE Dual Mobility Liner
K200854 · LPH
Depuy Ireland UC
Orthopedic · 164d
Cleared Sep 11, 2020
Fitbit ECG App
K200948 · QDA
Fitbit, Inc.
Cardiovascular · 156d
Cleared Sep 11, 2020
PERFORM Humeral System – Stem
K201315 · PAO
Tornier, Inc.
Orthopedic · 116d
Cleared Sep 11, 2020
SABER .035 PTA Dilatation Catheter
K201333 · LIT
Cordis Corporation
Cardiovascular · 115d
Cleared Sep 11, 2020
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical...
K201506 · ODP
Meditech Spine, LLC
Orthopedic · 98d
Cleared Sep 11, 2020
PF4 Enhanced assay
K201570 · LCO
Immucor Gti Diagnostics, Inc.
Hematology · 92d
Cleared Sep 11, 2020
HotDog Temperature Management Controller
K201779 · DWJ
Augustine Temperature Management
Cardiovascular · 73d
Cleared Sep 11, 2020
Porcine Mineral Collagen Composite Moldable
K201859 · NPM
Collagen Matrix, Inc.
Dental · 67d
Cleared Sep 11, 2020
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
K201959 · HRS
DePuy Synthes
Orthopedic · 59d
Cleared Sep 11, 2020
Dynex Micro
K202143 · KTT
Vilex, LLC
Orthopedic · 42d
Cleared Sep 11, 2020
FLEX Vessel Prep System
K202187 · PNO
Venturemed Group, Inc.
Cardiovascular · 38d
Cleared Sep 11, 2020
Aline Ablation Intelligence
K202297 · LLZ
Mirada Medical, Ltd.
Radiology · 29d
Cleared Sep 10, 2020
DSM Biomedical Dental Bone Graft Plus
K193212 · NPM
Dsm Biomedical
Dental · 294d
Cleared Sep 10, 2020
RGK Daily Range Wheelchairs
K200135 · IOR
Rgk Wheelchairs, Ltd.
Physical Medicine · 233d
Cleared Sep 10, 2020
Navigation Module of the Momentum System
K200845 · OLO
Ulrich Medical USA
Orthopedic · 163d
Cleared Sep 10, 2020
X-Pac Expandable Lumbar Cage System
K201145 · MAX
Expanding Innovations, Inc.
Orthopedic · 134d
Cleared Sep 10, 2020
Tigereye CTO-Crossing Catheter
K201330 · PDU
Avinger, Inc.
Cardiovascular · 114d
Cleared Sep 10, 2020
CD Horizon™ Spinal System
K201407 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Sep 10, 2020
Straight T Clear Dental Aligner
K201450 · NXC
Straight T, Inc.
Dental · 101d
Cleared Sep 10, 2020
Diode Laser Body Sculpture System
K201731 · PKT
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 78d
Cleared Sep 10, 2020
SubNovii Advanced Plasma Technology
K201738 · GEI
Cartessa Aesthetics
General & Plastic Surgery · 77d
Cleared Sep 10, 2020
RxSight Contact Lens
K201909 · HJK
Rxsight, Inc.
Ophthalmic · 63d
Cleared Sep 10, 2020
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
K201944 · JEY
Synthes USA Products, LLC
Dental · 59d
Cleared Sep 10, 2020
Disposable Vinyl Glove
K202008 · LYZ
Best Care Trading Co., Ltd.
General Hospital · 51d