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
153409–153432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1984
DETERMIN. OF SALICYLATE IN SERUM/PLAST
K840243 · DKJ
Sigma Chemical Co.
Chemistry · 63d
Cleared Mar 23, 1984
HDL CHOLESTEROL CONTROLS-LEVELS
K840278 · JIX
Preventive Diagnostics Corp.
Chemistry · 60d
Cleared Mar 23, 1984
PH ELECTRODE CALIBRATING BUFFERS-BLOOD
K840299 · JIS
Bionostics, Inc.
Chemistry · 59d
Cleared Mar 23, 1984
FLUSH SOLUTION CONCENTRATE-BLOOD GAS
K840300 · CHL
Bionostics, Inc.
Chemistry · 59d
Cleared Mar 23, 1984
CHEM-STAT ANALYZER
K840340 · JJQ
Ocean Scientific, Inc.
Chemistry · 58d
Cleared Mar 23, 1984
EMIT ST SERUM ETHYL ALCOHOL ASSAY
K840400 · DML
Syva Co.
Toxicology · 53d
Cleared Mar 23, 1984
HEXCELITE
K840416 · ITG
Hexcel Medical
Physical Medicine · 52d
Cleared Mar 23, 1984
HARRINGTON-TYPE INSTRU-SCOLIOSIS
K840423 · KWP
Link America, Inc.
Orthopedic · 52d
Cleared Mar 23, 1984
AMICON DIAFILTER 40. HEMOFILTER
K840449 · KDI
Medical Device Consultants, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 23, 1984
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
K840454 · LBI
Air-Shields, Inc.
General Hospital · 60d
Cleared Mar 23, 1984
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
K840461 · DON
Corning Medical & Scientific
Toxicology · 50d
Cleared Mar 23, 1984
SDL LISTERIA MONOCYTOGENES CONTROL
K840503 · GSI
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
SDL NEISSERIA MENINGITIDES GR. 2
K840504 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
SDL NEISSERIA MENNINGITIDIS GR. X
K840505 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. Y
K840507 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. C
K840508 · JTO
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. B
K840509 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. A
K840510 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. D
K840511 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS PNEUMONIAE CONTROL
K840512 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. B CONTROL
K840513 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS CONTROL
K840514 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · DGC
Pharmacia, Inc.
Immunology · 44d
Cleared Mar 23, 1984
BLOOD CONCENTRATOR 140
K840543 · KDI
Gambro, Inc.
Gastroenterology & Urology · 44d