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
153649–153672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1984
AMYLOID STAIN, CONGO RED HT 60
K840798 · ICH
Sigma Chemical Co.
Pathology · 18d
Cleared Mar 12, 1984
SCAVENGER TUBING 19MM
K840849 · CBN
The Kendal Co.
Anesthesiology · 17d
Cleared Mar 12, 1984
FORMALIN SOLUTION 10% NEUTRAL BUFFER
K840926 · IFP
Sigma Chemical Co.
Pathology · 10d
Cleared Mar 09, 1984
OMEGA 5000
K833978 · DXN
Invivo Research Labs, Inc.
Cardiovascular · 113d
Cleared Mar 09, 1984
AUTOGROUPER 16C SYS AUTOMATED REAG
K834149 · GMQ
Technicon Instruments Corp.
Microbiology · 99d
Cleared Mar 09, 1984
STRATUS THYROID UPTAKE FLUOROMETRIC
K834209 · KHQ
American Dade
Chemistry · 95d
Cleared Mar 09, 1984
AMS GRAM-NEGATIVE IDENT. CARD
K834269 · JTO
Vitek Systems, Inc.
Microbiology · 92d
Cleared Mar 09, 1984
TRI-COUNT 10
K834371 · JPK
Hematology Marketing Assoc.
Hematology · 87d
Cleared Mar 09, 1984
AMS GRAM-POSITIVE IDENT. CARD
K834389 · JTO
Vitek Systems, Inc.
Microbiology · 86d
Cleared Mar 09, 1984
APSARA ANALYZER
K834534 · JJE
Datachem, Inc.
Chemistry · 78d
Cleared Mar 09, 1984
LEECO E2 QUANT DIAG. TEST KIT
K834586 · CHP
Leeco Diagnostics, Inc.
Chemistry · 71d
Cleared Mar 09, 1984
AVL MODEL 945 BLOOD GAS SYSTEM
K834601 · CHL
Avl Scientific Corp.
Chemistry · 70d
Cleared Mar 09, 1984
SDI PREPAX DILUKIT 29-1000
K840044 · JJO
Scientific Distributors, Inc.
Toxicology · 63d
Cleared Mar 09, 1984
ORION BIOFEEDBACK DATA ACQUISITION
K840223 · HCC
Self Regulation Systems, Inc.
Neurology · 50d
Cleared Mar 09, 1984
ALLERCOAT MULTISCREEN DISCS
K840360 · DHB
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Mar 09, 1984
DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO
K840404 · DAD
Tago, Inc.
Immunology · 38d
Cleared Mar 09, 1984
ACID FAST BACILLI STAIN CONTROL
K840515 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 32d
Cleared Mar 09, 1984
METACHROMATIC GRANULE STAIN CONTROL
K840516 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 32d
Cleared Mar 09, 1984
PROTOZOA STAIN CONTROL
K840517 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 32d
Cleared Mar 09, 1984
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K840539 · BTO
Shiley, Inc.
Anesthesiology · 30d
Cleared Mar 09, 1984
LIQUI ZYME TOTAL BILIRUBIN REAGENT
K840564 · CIG
American Research Products Co.
Chemistry · 30d
Cleared Mar 09, 1984
TRI-TUBE RIA
K840589 · KHQ
Nuclear Medical Laboratories, Inc.
Chemistry · 29d
Cleared Mar 09, 1984
YERSINIA SUPPLEMENT
K840615 · JSI
Remel Co.
Microbiology · 25d
Cleared Mar 09, 1984
POIRIER COMMODES
K840639
Poirier S.A.
Physical Medicine · 49d