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
313–336 of 1,109
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Dec 07, 1992
CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-251
K924618 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101
K924619 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS, CATALOG #03-101
K924620 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS, CATALOG #02-101
K924621 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, CATALOG #02-201
K924622 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, CATALOG #03-201
K924623 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201
K924624 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT HLNFS CELLS, CATLOG #03-151
K924625 · KIR
Proteins Intl., Inc.
Pathology · 87d
Cleared Jun 09, 1992
BACTIDROP KOH (10%)
K920970 · JTS
Remel Co.
Pathology · 99d
Cleared Jun 09, 1992
BACTIDROP CALCOFLUOR WHITE
K920975 · JTS
Remel Co.
Pathology · 99d
Cleared Jun 09, 1992
BACTIDROP INDIA INK
K920976 · JTS
Remel Co.
Pathology · 99d
Cleared Mar 23, 1992
OPUS RUBELLA TEST SYSTEM
K915870 · LFX
Pb Diagnostics, Inc.
Pathology · 83d
Cleared Oct 31, 1991
ACLAIMS-IS
K912085 · LNJ
W-Technology
Pathology · 171d
Cleared Dec 18, 1990
NITRO BLUE TETRAZOLIUM REDUCTION
K904022 · GHD
Sigma Chemical Co.
Pathology · 110d
Cleared Dec 13, 1990
NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT
K903995 · GHD
Sigma Chemical Co.
Pathology · 106d
Cleared Sep 24, 1990
BARTELS EXTRACELLULAR MATRIX
K902726 · KIR
Baxter Healthcare Corp
Pathology · 95d
Cleared Aug 20, 1990
GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.
K902311 · LNJ
Applied Imaging Corp.
Pathology · 89d
Cleared Feb 26, 1990
1400 SERIES EVIDENCE COLLECTION KIT
K896373 · GIM
Transidyne General Corp.
Pathology · 112d
Cleared Feb 09, 1990
AKS II
K895095 · LNJ
Amoco Technology Co.
Pathology · 179d
Cleared Feb 01, 1990
MADIN-DARBY CANINE KIDNEY CULTURE CELLS
K896846 · KIR
Baxter Healthcare Corp
Pathology · 58d
Cleared Aug 04, 1989
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
K893508 · JFH
Baxter Healthcare Corp
Pathology · 91d
Cleared Jul 25, 1989
MODIFIED POLYCHROME IV STAIN
K894045 · KFD
Devetec, Inc.
Pathology · 48d
Cleared Jun 23, 1989
LIFECELL RECOVERY CONTAINER
K893787 · KJF
Baxter Healthcare Corp
Pathology · 32d
Cleared Jun 22, 1989
TISSUE EMBEDDING MEDIUM
K893772 · KEO
Stephens Scientific
Pathology · 31d