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
28129–28152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2017
MicroSTAAR Injector System Cartridges
K172375 · MSS
STAAR Surgical Company
Ophthalmic · 30d
Cleared Sep 06, 2017
Steerable Guide Catheter
K172394 · DRA
Abbott Vascular
Cardiovascular · 29d
Cleared Sep 05, 2017
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
K163464 · BZD
Bmc Medical., Ltd.
Anesthesiology · 270d
Cleared Sep 05, 2017
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2...
K163525 · DBM
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Sep 05, 2017
Relieva SpinPlus Nav Balloon Sinuplasty System
K171687 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 90d
Cleared Sep 05, 2017
FluidSmart
K172048 · HIG
Thermedx, LLC
Obstetrics & Gynecology · 61d
Cleared Sep 01, 2017
Senographe Pristina
K163302 · MUE
Ge Healthcare
Radiology · 283d
Cleared Sep 01, 2017
OMNIBotics Knee System
K163338 · OLO
Omnllife Science, Inc.
Orthopedic · 277d
Cleared Sep 01, 2017
NaviENT
K163439 · HAW
Claronav, Inc.
Neurology · 267d
Cleared Sep 01, 2017
GrindCare System
K163448 · HCC
Sunstar Suisse S.A.
Neurology · 267d
Cleared Sep 01, 2017
Prizma
K170181 · DXH
G-Medical Innovations , Ltd.
Cardiovascular · 225d
Cleared Sep 01, 2017
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
K170210 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 220d
Cleared Sep 01, 2017
Arthrex Mesh Plate System
K170547 · HRS
Arthrex, Inc.
Orthopedic · 189d
Cleared Sep 01, 2017
Epilaser
K170970 · GEX
Epilady 2000, LLC
General & Plastic Surgery · 154d
Cleared Sep 01, 2017
Carefusion NeutraClear Needle-free connector (EL-NC1000)
K171117 · FPA
Cair Lgl
General Hospital · 140d
Cleared Sep 01, 2017
BIOPHOTAS CELLUMA3
K171323 · OHS
Biophotas, Inc.
General & Plastic Surgery · 119d
Cleared Sep 01, 2017
Emprint SX Ablation Platform and Accessories
K171358 · NEY
Coviden, LLC
General & Plastic Surgery · 115d
Cleared Sep 01, 2017
CustomizedBone Service
K171507 · GXN
Fin-Ceramica Faenza S.P.A.
Neurology · 101d
Cleared Sep 01, 2017
ExsoMed ITN Cannulated Screw System
K171558 · HWC
Exsomed Holdings Company, LLC
Orthopedic · 94d
Cleared Sep 01, 2017
RhythmView Workstation
K171583 · DQK
Abbott Electrophysiology
Cardiovascular · 93d
Cleared Aug 31, 2017
Kelowna GYN and Crook Prostate Templates
K162533 · JAQ
Varian Medical Systems, Inc.
Radiology · 356d
Cleared Aug 31, 2017
Integrated Catch-up Freedom Syringe Driver Infusion System
K162613 · FRN
Repro-Med Systems, Inc. Dba Rms...
General Hospital · 346d
Cleared Aug 31, 2017
Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter...
K163337 · FLE
Midmark Corporation
General Hospital · 276d
Cleared Aug 31, 2017
NLZ Motor System
K163402 · EBW
Nakanishi, Inc.
Dental · 269d