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.

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

Filters: Cleared only ×
175,230 results
169993–170016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1979
HEPARSORB
K781781 · GJA
General Diagnostics
Hematology · 83d
Cleared Jan 10, 1979
BUN
K781782 · CDQ
Gilford Diagnostics
Chemistry · 83d
Cleared Jan 10, 1979
FERRITIN KIT
K781844 · JMG
Ria Products, Inc.
Chemistry · 70d
Cleared Jan 10, 1979
ASSAY SYSTEM, FERRITIN I KIT
K781888 · JMG
New England Nuclear
Chemistry · 64d
Cleared Jan 10, 1979
STAT KIT, MICROPROTEIN
K781897 · CEK
Pierce Chemical Co.
Chemistry · 58d
Cleared Jan 10, 1979
CALCITONIN 125
K781909 · JKR
Cambridge Nuclear Radiopharmaceutical
Chemistry · 57d
Cleared Jan 10, 1979
DATA MODULE
K781915 · KIE
Waters Assoc., Inc.
Chemistry · 57d
Cleared Jan 10, 1979
RIA KIT, GAMMADAB ESTRIOL
K781938 · CGI
Clinical Assays, Inc.
Chemistry · 51d
Cleared Jan 10, 1979
REAGENT KIT, TRIGLYCERIDES
K781939 · CDT
Beckman Instruments, Inc.
Chemistry · 51d
Cleared Jan 10, 1979
RIA KIT, FERRITIN SOLID PHASE
K781946 · JMG
Bd Becton Dickinson Vacutainer...
Chemistry · 50d
Cleared Jan 10, 1979
CRYOSURGICAL DEVICE 2000
K781956 · GEH
Valleylab, Inc.
General & Plastic Surgery · 50d
Cleared Jan 10, 1979
ANALYTICAL TEST PACK, PRIMIDONE
K781957 · DJD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 50d
Cleared Jan 10, 1979
ANALYTICAL TEST PACK, CARBAMAZEPINE
K781958 · KLT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 50d
Cleared Jan 10, 1979
SURGICAL GOWNS, SHEETS
K781959 · KKX
Convertors
General Hospital · 50d
Cleared Jan 10, 1979
HORMONE KIT, PARATHYROID
K782010 · CEW
Nichols Institute Diagnostics
Chemistry · 40d
Cleared Jan 10, 1979
ANALYZER ABA-200
K782014 · JJE
Abbott Laboratories
Chemistry · 36d
Cleared Jan 10, 1979
MONITOR HS8
K782044 · BZQ
Scientific & General Pty. , Ltd.
Anesthesiology · 33d
Cleared Jan 10, 1979
MONITOR HS7
K782045 · BZQ
Scientific & General Pty. , Ltd.
Anesthesiology · 33d
Cleared Jan 10, 1979
C-CORD
K782046 · FFZ
Concept, Inc.
Gastroenterology & Urology · 33d
Cleared Jan 10, 1979
EMIT PROCAINAMIDE CONTROL SET
K782084 · LAS
Syva Co.
Toxicology · 27d
Cleared Jan 10, 1979
STOCKINETTE, DISPOSABLESURGICAL
K782091 · KKX
Anago, Inc.
General Hospital · 27d
Cleared Jan 10, 1979
ARMBOARD CVER, DISPOSABLE
K782092 · FSE
Anago, Inc.
General & Plastic Surgery · 27d
Cleared Jan 10, 1979
RIA TEST, NORDICALB HPL
K782099 · JMF
Nordiclab Intl.
Immunology · 23d
Cleared Jan 10, 1979
MULTIPLICITY OF PRODUCTS
K782123 · HRS
Depuy, Inc.
Orthopedic · 14d