FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
18553–18576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 10, 2020
DIAMOND-5A/6A/8A
K202156 · KPR
DRGEM Corporation
Radiology · 45d
Cleared Sep 10, 2020
HS Fiber
K202242 · GAT
Riverpoint Medical, LLC
General & Plastic Surgery · 31d
Cleared Sep 09, 2020
MINT Product Family
K192423 · NEW
Hans Biomed Corporation
General & Plastic Surgery · 371d
Cleared Sep 09, 2020
Perseus
K192653 · OLO
Orthokey Italia S.R.L.
Orthopedic · 351d
Cleared Sep 09, 2020
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
K192730 · CHW
Biosystems S.A.
Chemistry · 348d
Cleared Sep 09, 2020
Benesta Hysteroscope
K192822 · HIH
Caldera Medical, Inc.
General Hospital · 344d
Cleared Sep 09, 2020
Vista Rinse, Vista Rinse Plus
K193409 · KJJ
Inter-Med/Vista Dental Products
Dental · 275d