FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
24841–24864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2018
Endoscope Sterilization Tray
K180964 · KCT
Intuitive Surgical, Inc.
General Hospital · 169d
Cleared Sep 28, 2018
Libertas Hip Replacement System
K180973 · JDI
Maxx Orthopedics, Inc.
Orthopedic · 168d
Cleared Sep 28, 2018
BioHorizons CAD/CAM Bars
K180998 · NHA
BioHorizons Implant Systems, Inc.
Dental · 165d
Cleared Sep 28, 2018
TSP Crosser Transseptal Access System
K181088 · DYB
Transseptal Solutions , Ltd.
Cardiovascular · 156d
Cleared Sep 28, 2018
Acessa ProVu System
K181124 · HFG
Acessa Health, Inc.
Obstetrics & Gynecology · 151d
Cleared Sep 28, 2018
E-CUBE 12
K181277 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Sep 28, 2018
Prime&Bond active Universal Adhesive
K181476 · KLE
Dentsply Sirona
Dental · 115d
Cleared Sep 28, 2018
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
K181652 · GAM
Ethicon, Inc.
General & Plastic Surgery · 98d
Cleared Sep 28, 2018
MICRORAPTOR Knotless Suture Anchor
K181746 · MAI
Smith and Nephew, Inc.
Orthopedic · 88d
Cleared Sep 28, 2018
RightEye Vision System
K181771 · GWN
Righteye, LLC
Ophthalmic · 87d
Cleared Sep 28, 2018
Truliant Porous Femoral Components
K181794 · MBH
Exactech, Inc.
Orthopedic · 85d
Cleared Sep 28, 2018
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
K182039 · PHX
Arthrex, Inc.
Orthopedic · 60d
Cleared Sep 28, 2018
Harmony
K182376 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 28d
Cleared Sep 28, 2018
Alphenix, INFX-8000F/B, V8.0
K182415 · OWB
Canon Medical Systems Corporation
Radiology · 24d
Cleared Sep 27, 2018
CRP Vario
K173833 · NQD
SENTINEL CH. SpA
Chemistry · 283d
Cleared Sep 27, 2018
EmboCube Embolization Gelatin
K181021 · KRD
Biosphere Medical, S.A.
Cardiovascular · 163d
Cleared Sep 27, 2018
PureSet Tray
K181075 · KCT
Nobel Biocare AB
General Hospital · 156d
Cleared Sep 27, 2018
DualX
K181397 · MAX
Innovasive, Inc.
Orthopedic · 121d
Cleared Sep 27, 2018
Disposable Standard Clamp
K181608 · GCJ
Standard Bariatrics
General & Plastic Surgery · 100d
Cleared Sep 27, 2018
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K181742 · KWS
Stryker GmbH
Orthopedic · 87d
Cleared Sep 27, 2018
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
K181975 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 65d
Cleared Sep 27, 2018
Acculoc Total Knee System
K182370 · JWH
Rootloc Co., Ltd.
Orthopedic · 27d
Cleared Sep 27, 2018
CarboClear® Pedicle Screw System
K182377 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 27d
Cleared Sep 27, 2018
CoLink View Plating System
K182402 · HRS
In2bones USA, LLC
Orthopedic · 23d