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

Filters: Cleared only ×
175,820 results
22945–22968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2019
MTS Doxycycline 0.016 - 256 µg/mL
K190914 · JWY
Liofilchem S. R. L.
Microbiology · 51d
Cleared May 29, 2019
3M RelyX Pediatric Resin Modified Glass Ionomer Cement
K191122 · EMA
3M Espe Dental Products
Dental · 30d
Cleared May 29, 2019
Swiss LithoClast Trilogy
K191124 · FFK
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 30d
Cleared May 29, 2019
uMR 780, uMR 790
K191157 · LNH
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared May 28, 2019
Clearlink System Solution Set
K180739 · FPA
Baxter Healthcare Corporation
General Hospital · 432d
Cleared May 28, 2019
AccelFix Spinal Fixation System
K182544 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 253d
Cleared May 28, 2019
Nihon Kohden SVM-7200 Series Vital Signs Monitor
K190468 · MWI
Nihon Kohden Corporation
Cardiovascular · 91d
Cleared May 28, 2019
MectaLock PEEK Suture Anchor
K190474 · MBI
Medacta International S.A.
Orthopedic · 90d
Cleared May 28, 2019
IGNITE Bone Void Filler
K190482 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared May 28, 2019
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K190606 · LZA
Kossan International Sdn Bhd
General Hospital · 81d
Cleared May 28, 2019
Optilite IgM CSF Kit
K190686 · CFN
The Binding Site Group , Ltd.
Immunology · 71d
Cleared May 27, 2019
Surgical Face Mask
K182515 · FXX
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 257d
Cleared May 24, 2019
Conical Plus Implant System
K181157 · DZE
Osseofuse International, Inc.
Dental · 388d
Cleared May 24, 2019
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
K181979 · KOD
Teleflexmedical, Inc.
Gastroenterology & Urology · 303d
Cleared May 24, 2019
MobileLink Acetabular Cup System
K182321 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 270d
Cleared May 24, 2019
Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K182575 · LYZ
Jiangxi Jaysun Medcare Co., Ltd.
General Hospital · 247d
Cleared May 24, 2019
TruDiagnosis System
K183530 · ODW
Akonni Biosystems, Inc.
Toxicology · 156d
Cleared May 24, 2019
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator...
K190077 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 128d
Cleared May 24, 2019
InCore® Lapidus Sterile Kits
K190231 · HWC
Nextremity Solutions, Inc.
Orthopedic · 107d
Cleared May 24, 2019
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
K190282 · DTQ
Spectrum Medical , Ltd.
Cardiovascular · 102d
Cleared May 24, 2019
Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge,...
K190378 · KNW
Bioncise NV
Obstetrics & Gynecology · 94d
Cleared May 24, 2019
LightLas Pattern Scanning System - TruScan Pro
K190448 · HQF
Light-Med(Usa), Inc.
Ophthalmic · 88d
Cleared CT May 24, 2019
Soliton Acoustic Wave Device
K190542 · GEX
Soliton, Inc.
General & Plastic Surgery · 81d
Cleared May 24, 2019
Tria Firm Ureteral Stent
K190603 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 77d