FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Pathology ×
1,109 results
721–744 of 1,109
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Oct 22, 1985
GRAM STAIN KIT
K853896 · JTS
Sigma Diagnostics, Inc.
Pathology · 32d
Cleared Oct 22, 1985
XYLENE SUBSTITUTE MONTANT
K854083 · KEM
Lerner Laboratories, Inc.
Pathology · 15d
Cleared Oct 15, 1985
FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB
K853803 · KIS
Z.L. Bocknek Laboratories, Inc.
Pathology · 34d
Cleared Oct 10, 1985
LX 300 TISSUE PROCESSOR
K853938 · IEO
Innovative Medical Systems, Inc.
Pathology · 16d
Cleared Sep 16, 1985
CORNING CELL WELLS-MULTIPLE WELL PLATES
K853634 · KIZ
Corning Medical & Scientific
Pathology · 17d
Cleared Aug 28, 1985
LX EMBEDDING CENTER
K853463
Innovative Medical Systems, Inc.
Pathology · 9d
Cleared Aug 28, 1985
PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN
K853497 · IFP
Surgipath Medical Industries, Inc.
Pathology · 8d
Cleared Aug 26, 1985
FETAL BOVINE SERUM IN TRANSFER CONTAINER
K853441 · KJA
Newport Biosystems, Inc.
Pathology · 13d
Cleared Aug 19, 1985
HEMATOLOGY STAIN PACK
K853241 · IAF
Fisher Scientific Co., LLC
Pathology · 18d
Cleared Aug 13, 1985
AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
K853081 · KJK
Advanced Medical Technology, Inc.
Pathology · 21d
Cleared Aug 13, 1985
ACRIDINE ORANGE FLUORESCENT STAIN
K853187 · IDC
Advanced Medical Technology, Inc.
Pathology · 14d
Cleared Aug 12, 1985
ULTRACLONE ECL-01-2200 CELL LINE
K853203 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 13d
Cleared Jul 12, 1985
DUPONT PREP FOUR-SOLVENT RETROFIT KIT
K851393 · JJH
E.I. Dupont DE Nemours & Co., Inc.
Pathology · 94d
Cleared Jul 12, 1985
NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS
K851508 · LNJ
Nikon, Inc.
Pathology · 88d
Cleared Jul 12, 1985
MDCK
K852394 · KIR
Viromed Laboratories, Inc.
Pathology · 36d
Cleared Jul 12, 1985
MINK LUNG
K852395 · KIR
Viromed Laboratories, Inc.
Pathology · 36d
Cleared Jul 12, 1985
HEK
K852396 · KIR
Viromed Laboratories, Inc.
Pathology · 36d
Cleared Jul 12, 1985
CELLGRO WILLIAMS' MEDIUM E
K852475 · KIT
Mediatech, Inc.
Pathology · 31d
Cleared Jul 12, 1985
CELLGRO(ISCOVE'S MEDIUM) MODIFICATION
K852485 · KIT
Mediatech, Inc.
Pathology · 31d
Cleared Jul 12, 1985
BIOGLAS MICROCARRIER BEAD
K852506 · KJB
Solohill Engineering, Inc.
Pathology · 30d
Cleared Jul 12, 1985
MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON
K852568 · KIT
Sigma Chemical Co.
Pathology · 24d
Cleared Jul 12, 1985
MCCOY'S 5A MEDIUM-LIQUID FORM
K852602 · KIT
Mediatech, Inc.
Pathology · 23d
Cleared Jul 12, 1985
MCCOY'S 5A MEDIUM - POWDERED FORM
K852603
Mediatech, Inc.
Pathology · 23d
Cleared Jun 24, 1985
ELECTRA 800 AUTOMATIC COAGULATION TIMER
K851169 · KQG
Medical Laboratory Automation...
Pathology · 94d