FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

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

Filters: Pathology ×
1,105 results
865–888 of 1,105
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Jun 27, 1984
FORMA-FAS-TEST
K833128 · LIF
Chemical Detection & Experimentation
Pathology · 288d
Cleared Jun 26, 1984
PARAPLAST EXTRA TISSUE EMBEDDING MED.
K842053 · KEO
Sherwood Medical Co.
Pathology · 35d
Cleared Jun 22, 1984
HANKS BALANCED SALTS-HBSS H2387
K842002 · KIT
Sigma Chemical Co.
Pathology · 37d
Cleared Jun 07, 1984
WI-38
K841806 · KIR
Viromed Laboratories, Inc.
Pathology · 37d
Cleared May 22, 1984
SCOTTS TAP WATER SUBSTITUTE 7
K841423 · JCC
Reagent Laboratory, Inc.
Pathology · 47d
Cleared May 11, 1984
DULBECCO'S PHOSPHATE BUFFERED SALINE
K841744 · KIT
Sigma Chemical Co.
Pathology · 14d
Cleared May 07, 1984
RHESUS SV5/SV40
K841665 · KIR
Viromed Laboratories, Inc.
Pathology · 14d
Cleared May 07, 1984
RABBIT KIDNEY CELLS
K841666 · KIR
Viromed Laboratories, Inc.
Pathology · 14d
Cleared May 02, 1984
DECALCIFIER I
K841488 · KDX
Surgipath Medical Industries, Inc.
Pathology · 22d
Cleared Mar 23, 1984
TISSUE CULTURE REFEEDING MEDIUM
K834113 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 115d
Cleared Mar 22, 1984
HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN
K834117 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
MCCOY CELLS
K834119 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
LLC-MK2-RHESUS MONKEY KIDNEY CELLS
K834120 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
WI-38 HUMAN LUNG CELLS
K834123 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
VERO CELLS
K834124 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
MRC-5 CELLS
K834126 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
PBS W/MG+2 & CA+2
K834136 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 113d
Cleared Mar 12, 1984
AMYLOID STAIN, CONGO RED HT 60
K840798 · ICH
Sigma Chemical Co.
Pathology · 18d
Cleared Mar 12, 1984
FORMALIN SOLUTION 10% NEUTRAL BUFFER
K840926 · IFP
Sigma Chemical Co.
Pathology · 10d
Cleared Mar 05, 1984
DISPOSABLE SYRINGE FILTERS
K840556 · KET
Corning Medical & Scientific
Pathology · 26d
Cleared Feb 27, 1984
TITAN GEL SILVER STAIN SYSTEM
K833855 · CEF
Helena Laboratories
Pathology · 112d
Cleared Feb 04, 1984
BIOSPAL 2400S
K834579 · KDT
Hospal Medical Corp.
Pathology · 37d
Cleared Feb 04, 1984
AUTOTECHNICON V TISSUE PROCESS SYS
K834599 · IEO
Technicon Instruments Corp.
Pathology · 36d
Cleared Dec 22, 1983
BACTROL TB SLIDE
K833900
Difco Laboratories, Inc.
Pathology · 38d