FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76753–76776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9069
K013412 · MVO
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
K013650 · MUH
Sirona Dental Systems GmbH
Radiology · 30d
Cleared Dec 06, 2001
MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
K013659 · MUH
Sirona Dental Systems GmbH
Radiology · 30d
Cleared Dec 06, 2001
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
K013683 · GAW
Abbott Vascular, Inc.
General & Plastic Surgery · 29d
Cleared Dec 06, 2001
MEDLINE EXCEL RECLINCER WHEELCHAIR
K013761 · IOR
Medline Industries, Inc.
Physical Medicine · 23d
Cleared Dec 06, 2001
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
K013789 · DQY
Boston Scientific, Target
Cardiovascular · 22d
Cleared Dec 06, 2001
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
K013861 · HAW
Elekta Instrument AB
Neurology · 15d
Cleared Dec 05, 2001
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
K012014 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 176d
Cleared Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · NBW
Roche Diagnostics Corp.
Chemistry · 135d
Cleared Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302,...
K012988 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 90d
Cleared Dec 05, 2001
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
K013000 · GXN
Medtronic Neurosurgery
Neurology · 90d
Cleared Dec 05, 2001
FOCAL SIM
K013112 · MUJ
Computerized Medical Systems, Inc.
Radiology · 78d
Cleared Dec 05, 2001
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211 · KWY
Exactech, Inc.
Orthopedic · 70d
Cleared Dec 05, 2001
TCI-31 LIFELONG OVULATION TESTER
K013323 · CEP
Tci New York
Chemistry · 61d
Cleared Dec 05, 2001
ISITE RADIOLOGY
K013630 · LLZ
Stentor, Inc.
Radiology · 30d
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Dec 05, 2001
GENETRA
K013660 · KXK
Radiomed Corporation
Radiology · 29d
Cleared Dec 05, 2001
CEMENT RESTRICTOR
K013663 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 05, 2001
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
K013676 · MEH
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 05, 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · MNH
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 05, 2001
AUTOGENESIS AUTOMATOR, MODEL M1000
K013818 · JEC
Autogenesis, Inc.
Orthopedic · 19d
Cleared Dec 04, 2001
CTXA HIP
K002113 · KGI
Mindways Software, Inc.
Radiology · 545d
Cleared Dec 04, 2001
RANDOX PHENYTOIN
K011393 · DIP
Randox Laboratories, Ltd.
Toxicology · 211d
Cleared Dec 04, 2001
MILLCOMP
K011845 · IYE
Math Resolutions, LLC
Radiology · 175d