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
150001–150024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1985
MODIFY ELECTROLYTE ANALYZER MODEL SERA-210
K844806 · CEM
Horiba Instruments, Inc.
Chemistry · 28d
Cleared Jan 07, 1985
GLB VARICELLA-ZOSTER VIRUS FLUORESCENT
K842096 · GQX
Great Lakes Bioscience
Microbiology · 227d
Cleared Jan 07, 1985
COULTER MEAN PLATELET VOLUME CALIBRATOR
K843910 · KRY
Coulter Electronics, Inc.
Hematology · 96d
Cleared Jan 07, 1985
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
K843963 · FKQ
Renal Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 07, 1985
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
K844108 · FKX
Renal Systems, Inc.
Gastroenterology & Urology · 76d
Cleared Jan 07, 1985
CONCISE LIGHT CURED WHITE SEALANT
K844211 · EBC
3M Company
Dental · 68d
Cleared Jan 07, 1985
ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII
K844287 · GLZ
Apple Diagnostic Products
Microbiology · 63d
Cleared Jan 07, 1985
NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS
K844391 · DXH
Ams Medical, Inc.
Cardiovascular · 55d
Cleared Jan 07, 1985
ALBUMIN BCP
K844426 · CJW
Boehringer Mannheim Corp.
Immunology · 53d
Cleared Jan 07, 1985
V AGAR
K844513 · JSH
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
DTM AGAR
K844514 · JSH
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
VIOLET RED BILE AGAR
K844515 · JSI
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
STARCH HYDROLYSIS AGAR W/INDICATOR
K844516 · JSH
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
COLUMBIA CNA AGAR W/5% SHEEP BLOOD
K844517 · JSJ
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
STREPTOCOCCUS SELECTIVE AGAR
K844518 · JSJ
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
HAEMOPHILUS I.D. QUAD
K844519 · JSH
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
KLIGER IRON AGAR
K844520 · JSH
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
SIM MEDIUM
K844521 · JSH
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
SF BROTH
K844522 · JSH
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
CAMPYLOBACTER THIOGLYCOLLATE MEDIUM
K844523 · JSJ
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
GN BROTH
K844524 · JSJ
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
SELENITE CYSTINE BROTH
K844525 · JSJ
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR
K844526 · JSG
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
SELENITE BROTH
K844527 · JSJ
bioMerieux, Inc.
Microbiology · 47d