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
745–768 of 1,105
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Jun 04, 1985
RMK GENCELLS CULTURE SYSTEM
K852205 · KIR
Genus Diagnostics
Pathology · 14d
Cleared Jun 04, 1985
HEP-2 GENCELLS
K852206 · KIR
Genus Diagnostics
Pathology · 14d
Cleared Jun 04, 1985
CELLGRO
K852288 · KIT
Mediatech, Inc.
Pathology · 6d
Cleared May 20, 1985
MCDB 302 MEDIUM, M2021
K851862 · KIT
Sigma Cell Culture Reagents
Pathology · 24d
Cleared May 20, 1985
NCTC-135 MEDIUM N3262
K851863 · KIT
Sigma Cell Culture Reagents
Pathology · 24d
Cleared May 20, 1985
VERO GENCELLS
K851927 · KIR
Genus Diagnostics
Pathology · 18d
Cleared May 20, 1985
HEK GENCELLS
K851928 · KIR
Genus Diagnostics
Pathology · 18d
Cleared May 15, 1985
LX120 TISSUE PROCESSOR
K851054 · IEO
Innovative Medical Systems, Inc.
Pathology · 62d
Cleared May 15, 1985
CRCM-30 MEDIUM PRODUCT NO. C5030
K851604 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
SWIN'S S-77 MEDIUM, PRODUCTS S2513
K851605 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
D-PBS, PRODUCTS NO. D5652
K851606 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
MCDB 151 MEDIUM, PRODUCT NO. M6645
K851607 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
SFRE199-1 MEDIUM PRODUCT NO. S 2013
K851608 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
SFRE 199-2 MEDIUM, PRODUCTS NO. S2138
K851609 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 10, 1985
ULTRACLONE ECL-01-800 CELL LINE
K851545 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 24d
Cleared May 10, 1985
WI-38 GENCELLS
K851561 · KIR
Genus Diagnostics
Pathology · 24d
Cleared May 10, 1985
MRC-5 GENCELLS
K851562 · KIR
Genus Diagnostics
Pathology · 24d
Cleared May 10, 1985
RK GENCELLS
K851563 · KIR
Genus Diagnostics
Pathology · 24d
Cleared Apr 29, 1985
SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR
K851481 · LED
Difco Laboratories, Inc.
Pathology · 14d
Cleared Apr 29, 1985
KINYOUN ACID FAST STAIN KIT
K851493 · JTS
Accra Laboratories, Inc.
Pathology · 14d
Cleared Apr 29, 1985
TWO-STEP ACID FAST BACTERIA STAIN
K851494 · JTS
Accra Laboratories, Inc.
Pathology · 14d
Cleared Apr 19, 1985
COMPRESSION HIP SCREW SYSTEM
K850886 · KIT
Pfizer, Inc.
Pathology · 46d
Cleared Mar 29, 1985
TRYPSIN-EDTA SOLUTION
K850679 · KIT
Hazleton Research Products, Inc.
Pathology · 36d
Cleared Mar 25, 1985
SPRAYFIX
K850916 · PPM
Surgipath Medical Industries, Inc.
Pathology · 20d