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
6601–6624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2024
MRI Universal
K240651 · JEY
Stryker Leibinger GmbH & Co KG
Dental · 127d
Cleared Jul 12, 2024
“MoFi” Cell Culture Basal Medium
K240247 · NDS
Duogenic Stemcells Corporation
Gastroenterology & Urology · 164d
Cleared Jul 12, 2024
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®,...
K240240 · NHA
Prismatik Dentalcraft, Inc.
Dental · 164d
Cleared Jul 12, 2024
Single Use Hemoclips
K234124 · PKL
Promisemed Hangzhou Meditech Co., Ltd.
Gastroenterology & Urology · 197d
Cleared Jul 12, 2024
SPIRA® Anterior Lumbar Spacers
K234077 · MAX
Camber Spine Technologies
Orthopedic · 203d
Cleared Jul 12, 2024
Acorn 3D Software (AC-SEG-4009)
K234009 · QIH
Mighty Oak Medical
Radiology · 206d
Cleared Jul 12, 2024
Infinity Gateway Suite
K233834 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 221d
Cleared Jul 12, 2024
Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne...
K233644 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 242d
Cleared Jul 12, 2024
HemoCare Hemodialysis System
K233557 · KDI
Deka Research and Development
Gastroenterology & Urology · 249d
Cleared Jul 12, 2024
RUS
K233457 · QIH
Hutom, Inc.
Radiology · 266d
Cleared Jul 12, 2024
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
K232372 · GAM
Peters Surgical
General & Plastic Surgery · 339d
Cleared Jul 11, 2024
Cytal® Wound Matrix
K241724 · KGN
Acell, Inc.
General & Plastic Surgery · 27d
Cleared Jul 11, 2024
Oscar Peripheral Multifunctional Catheter system
K241711 · LIT
Biotronik, Inc.
Cardiovascular · 27d
Cleared Jul 11, 2024
MicroMatrix® UBM Particulate
K241706 · KGN
Acell, Inc.
General & Plastic Surgery · 28d
Cleared Jul 11, 2024
Manual Wheelchair
K241460 · IOR
Lichtmega Technology Co., Ltd.
Physical Medicine · 49d
Cleared Jul 11, 2024
SubtleSYNTH (1.x)
K241329 · QIH
Subtle Medical, Inc.
Radiology · 62d
Cleared Jul 11, 2024
Sterile single use tip cleaner (WK800-S10 , WK800-S20)
K241022 · GEI
Wickimed (Huizhou) Medical Equipment...
General & Plastic Surgery · 87d
Cleared Jul 11, 2024
Natural Cycles
K241006 · PYT
Natural Cycles Nordic AB
Obstetrics & Gynecology · 90d
Cleared Jul 11, 2024
ATTUNE™ Revision Knee System
K241000 · JWH
Depuy Ireland UC
Orthopedic · 90d
Cleared Jul 11, 2024
CUSA® Clarity Ultrasonic Surgical Aspirator System
K240493 · LFL
Integra LifeSciences Corporation
Obstetrics & Gynecology · 142d
Cleared Jul 11, 2024
tmCMF Solution
K233874 · JEY
Techmah Cmf
Dental · 217d
Cleared Jul 11, 2024
Drivewire 24 Guidewire
K233791 · MOF
Rapid Medical , Ltd.
Neurology · 226d
Cleared Jul 10, 2024
Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )
K241683 · LIT
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 10, 2024
Mojo 2 Full Face Vented Mask
K241661 · BZD
Sleepnet Corporation
Anesthesiology · 30d