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
26257–26280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2018
Axis Anterior Cervical Plate System
K173867 · KWQ
Axis Orthopaedics
Orthopedic · 106d
Cleared Apr 05, 2018
syngo.via MI Workflows
K173897 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 104d
Cleared Apr 05, 2018
Medacta Shoulder System Short Humeral Diaphysis
K180089 · PHX
Medacta International S.A.
Orthopedic · 83d
Cleared Apr 05, 2018
PowerLook Density Assessment Software
K180125 · LLZ
Icad, Inc.
Radiology · 79d
Cleared Apr 05, 2018
TheraCal DC
K180344 · EJK
Bisco, Inc.
Dental · 56d
Cleared Apr 05, 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K180349 · NFT
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 56d
Cleared Apr 05, 2018
K2M Patient Specific Rods
K180376 · NKB
K2m, Inc.
Orthopedic · 52d
Cleared Apr 05, 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
K180378 · HKI
Optomed OY
Ophthalmic · 52d
Cleared Apr 05, 2018
DR 800 with MUSICA Dynamic
K180589 · JAA
Agfa Healthcare N.V.
Radiology · 30d
Cleared Apr 05, 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...
K180694 · MCW
Spectranetics, Inc.
Cardiovascular · 20d
Cleared Apr 04, 2018
Pulse Oximeter
K172141 · DQA
Shanghai Berry Electronic Tech Co., Ltd.
Anesthesiology · 261d
Cleared Apr 04, 2018
SIMPLANT 18
K172239 · LLZ
Dentsply Sirona
Radiology · 252d
Cleared Apr 04, 2018
Master-Frank N95 Particulate Respirator
K172963 · MSH
Master & Frank Enterprise Co., Ltd.
General Hospital · 190d
Cleared Apr 04, 2018
Algidex Ag Silver Alginate Wound Dressing
K173072 · FRO
Deroyal Industries, Inc.
General & Plastic Surgery · 187d
Cleared Apr 04, 2018
ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
K173074 · MBI
Stryker
Orthopedic · 187d
Cleared Apr 04, 2018
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
K173079 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 187d
Cleared Apr 04, 2018
Scenium VE20 Software
K173597 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Apr 04, 2018
The Pump by Babyation
K173699 · HGX
Babyation, LLC
Obstetrics & Gynecology · 121d
Cleared Apr 04, 2018
TrapLiner catheter
K180088 · DQY
Vascular Solutions, Inc.
Cardiovascular · 82d
Cleared Apr 04, 2018
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
K180339 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Apr 04, 2018
SYSTEM 1E Liquid Chemical Sterilant Processing System
K180342 · MED
Steris Corporations
General Hospital · 56d
Cleared Apr 04, 2018
MobileX Portable X-ray System
K180561 · EHD
Denterprise International, Inc.
Radiology · 30d
Cleared Apr 04, 2018
GammaPod
K180571 · IWB
Xcision Medical Systems, LLC
Radiology · 30d
Cleared Apr 04, 2018
SciMoCa
K180595 · IYE
Radialogica, LLC
Radiology · 29d