FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
193–216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2026
Avara Viewer
K262120 · LLZ
Avara Software
Radiology · 17d
Cleared Jul 10, 2026
WallFlex Esophageal Stent System
K261978 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Jul 10, 2026
NYES Tuff Cuff L3 Disposable Gowns
K261949 · FYA
New York Embroidery Studio
General Hospital · 29d
Cleared Jul 10, 2026
Omnifit® 20° Series I Insert
K261624 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Jul 10, 2026
AI Contouring (VA10A)
K261306 · QKB
Varian Medical Systems
Radiology · 81d
Cleared Jul 10, 2026
Flowflex Plus RSV + Flu A/B + COVID Rapid Test
K261212 · SCA
ACON Laboratories, Inc.
Microbiology · 87d
Cleared Jul 10, 2026
Electric Wheelchair (DY611A-2, DY612A-1)
K261149 · ITI
Zhejiang Lumbre Electric Appliance...
Physical Medicine · 93d
Cleared Jul 10, 2026
ClearSafe Closed System
K261041 · FOZ
MedSource Labs, LLC
General Hospital · 101d
Cleared Jul 10, 2026
POSEIDON ST
K261031 · MQP
Signus Medinzintechnik GmbH
Orthopedic · 102d
Cleared Jul 10, 2026
Cochlear™ Osia® 3(I) Sound Processor
K260902 · PFO
Cochlear Americas
Ear, Nose, Throat · 114d
Cleared Jul 10, 2026
SedLine Sedation Monitor
K260880 · OLW
Masimo Corporation
Anesthesiology · 115d
Cleared Jul 10, 2026
Sofia Lyme FIA
K254295 · LSR
Ortho-Clinical Diagnostics, Inc....
Microbiology · 191d
Cleared Jul 10, 2026
LungFlow Airway Catheter
K254037 · EOQ
Free Flow Medical, Inc.
Anesthesiology · 206d
Cleared Jul 10, 2026
SmartCT (R3.0 (L10))
K253670 · OWB
Philips Medical Systems B.V.
Radiology · 231d
Cleared Jul 10, 2026
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220)
K253514 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 246d
Cleared Jul 10, 2026
Capenergy C Equipments RF C200 and C400 Drakarian
K253480 · PBX
Capenergy Medical S.L.
General & Plastic Surgery · 269d
Cleared Jul 09, 2026
Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable...
K261988 · NEW
Teleflex Medical, LLC
General & Plastic Surgery · 27d
Cleared Jul 09, 2026
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue...
K261968 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jul 09, 2026
SmartGuard Technology
K261962 · QJI
Medtronic Minimed
Chemistry · 28d
Cleared Jul 09, 2026
UbiqVue™ 2AYe Cardiac System (UX2253)
K261569 · DRG
Lifesignals, Inc.
Cardiovascular · 58d
Cleared Jul 09, 2026
Zeta TMS Navigation System
K261471 · QFF
Zeta Surgical, Inc.
Neurology · 66d
Cleared Jul 09, 2026
PINKSLIP Water-Based Personal Lubricant and Moisturizer
K261177 · NUC
PINKSLIP, LLC
Obstetrics & Gynecology · 90d
Cleared Jul 09, 2026
DIA-CEM
K261166 · EMA
DiaDent Group International
Dental · 91d
Cleared Jul 09, 2026
HYDROS Robotic System (HY1000)
K260723 · PZP
Procept Biorobotics
Gastroenterology & Urology · 126d