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
23857–23880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2019
Earlens Contact Hearing Aid
K182480 · PLK
Earlens Corporation
Ear, Nose, Throat · 137d
Cleared Jan 25, 2019
Accucuff Cuff Pressure Indicator
K182548 · BSK
Tianjin Medis Medical Device Co., Ltd.
Anesthesiology · 130d
Cleared Jan 25, 2019
GenesisZr™ 4Y Zirconia
K182642 · EIH
United Dental Resources Corporation
Dental · 123d
Cleared Jan 25, 2019
Wilson-Cook Achalasia Balloon
K182895 · PID
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 102d
Cleared Jan 25, 2019
SI-Restore® Sacroiliac Joint Fixation System
K182919 · OUR
Biofusion Medical
Orthopedic · 98d
Cleared Jan 25, 2019
Hoffmann LRF System
K182968 · KTT
Stryker GmbH
Orthopedic · 91d
Cleared Jan 25, 2019
SMR Lateralized Connectors with screws
K183042 · KWS
Lima Corporate S.P.A.
Orthopedic · 84d
Cleared Jan 25, 2019
HammerToe Compression System
K183228 · HTY
Paragon 28, Inc.
Orthopedic · 66d
Cleared Jan 25, 2019
Treace Medical Concepts (TMC) Plating System
K183321 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 56d
Cleared CT Jan 25, 2019
Revive Reusable Bladder Support
K183468 · HHW
Rinovum Subsidiary 2, LLC
Gastroenterology & Urology · 42d
Cleared Jan 25, 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys...
K183615 · PQK
Avenu Medical, Inc.
Cardiovascular · 30d
Cleared Jan 25, 2019
medi pneumatic compression system (pcs) – brio (Model 651)
K183631 · JOW
Medi USA, LP
Cardiovascular · 30d
Cleared Jan 24, 2019
Ritter Dental Implant System
K180183 · DZE
Ritter Implants GmbH CO KG
Dental · 366d
Cleared Jan 24, 2019
Reprocessed CS Diagnostic Electrophysiology Catheter
K181056 · NLH
Stryker Sustainability Solutions
Cardiovascular · 279d
Cleared Jan 24, 2019
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135 · LCM
Immunalysis Corporation
Toxicology · 269d
Cleared Jan 24, 2019
Surveyor S2
K182297 · DRG
Mortara Instrument, Inc.
Cardiovascular · 153d
Cleared Jan 24, 2019
Zyppah Anti-Snoring Device
K182312 · LRK
Always More Marketing
Dental · 150d
Cleared Jan 24, 2019
BTL-703
K182363 · IMJ
BTL Industries, Inc.
Physical Medicine · 147d
Cleared Jan 24, 2019
Surgical Face Mask
K182514 · FXX
Xiantao Zhibo Non-Woven Products Co.,...
General Hospital · 134d
Cleared Jan 24, 2019
E-CUBE i7
K182594 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 126d
Cleared Jan 24, 2019
ROSA Knee System
K182964 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 91d
Cleared Jan 24, 2019
MAGNETOM Lumina
K183244 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Jan 24, 2019
FLOW 90 Wand
K183346 · GEI
ArthroCare Corporation
General & Plastic Surgery · 52d
Cleared Jan 24, 2019
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
K183541 · KPR
Prognosys Medical Systems Private...
Radiology · 35d