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
23905–23928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2019
Bright Guard
K181099 · OBR
Koncept Innovators, LLC
Dental · 267d
Cleared Jan 18, 2019
Reprocessed Visions PV .035 Digital IVUS Catheter
K181126 · OWQ
Innovative Health, LLC
Cardiovascular · 263d
Cleared Jan 18, 2019
Kurin PIV Blood Collection Set with High Pressure
K181895 · JKA
Kurin, Inc.
General Hospital · 186d
Cleared Jan 18, 2019
Aurora Surgiscope System
K182211 · GWG
Rebound Therapeutics Corporation
Neurology · 156d
Cleared Jan 18, 2019
Tyber Medical PT Interbody Spacer
K182284 · ODP
Tyber Medical, LLC
Orthopedic · 148d
Cleared Jan 18, 2019
PICO 7Y Single Use Negative Pressure Wound Therapy System
K182323 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 144d
Cleared Jan 18, 2019
AHMED ClearPath Glaucoma Drainage Device
K182518 · KYF
New World Medical, Inc.
Ophthalmic · 127d
Cleared Jan 18, 2019
MRI Compatibility for Existing Neodent Implant System
K182620 · DZE
Jjgc Industria E Comercio DE...
Dental · 116d
Cleared Jan 18, 2019
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM,...
K182782 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 109d
Cleared Jan 18, 2019
MUTYH-Associated Polyposis (MAP)
K182784 · QAZ
23AndMe, Inc.
Medical Genetics · 109d
Cleared Jan 18, 2019
Pristina Serena 3D
K182951 · MUE
Ge Healthcare
Radiology · 87d
Cleared Jan 18, 2019
Puffin Lite Infant Resuscitation System
K182956 · BTL
International Biomedical
Anesthesiology · 86d
Cleared Jan 18, 2019
SureForm 45, SureForm 45 Reloads
K183224 · NAY
Intuitive Surgical
General & Plastic Surgery · 59d
Cleared Jan 18, 2019
SIGNA Premier
K183231 · LNH
Ge Medical Systems, LLC
Radiology · 59d
Cleared Jan 18, 2019
Magnetom Vida
K183254 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Jan 18, 2019
Flex-THOR scope
K183264 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 56d
Cleared Jan 18, 2019
HardyDisk AST Omadacycline 30µg (OMC30)
K183298 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Jan 17, 2019
Savina 300
K180779 · CBK
Dragerwerk AG & CO Kgaa
Anesthesiology · 297d
Cleared Jan 17, 2019
Pinehurst Anterior Cervical Plate System
K181190 · KWQ
Signature Orthopaedics Pty, Ltd.
Orthopedic · 258d
Cleared Jan 17, 2019
Bodycad Unicompartmental Knee System
K181302 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 245d
Cleared Jan 17, 2019
Imboki Knee Instrument System
K181338 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 241d
Cleared Jan 17, 2019
ProgenaMatrix
K182010 · KGN
Cell Constructs I, LLC
General & Plastic Surgery · 174d
Cleared Jan 17, 2019
DL Self-adhesive Electrode
K182111 · GXY
Shaoxing DL Healthcare Co., Ltd.
Neurology · 164d
Cleared Jan 17, 2019
Esprit Nova
K182227 · OLZ
Neurozone Msh Incorporated
Neurology · 154d