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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11521–11544 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 17, 1981
AMICON ULTRAFILTRATION MEMBRANES CMII
K810810 · DHX
Amicon, Inc.
Chemistry · 24d
Cleared Apr 17, 1981
DRAINING-WOUND MGMT. SYSTEM
K810812 · EXB
Johnson & Johnson Professionals, Inc.
Chemistry · 24d
Cleared Apr 17, 1981
CHORIO-SHURE
K810936 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 10d
Cleared Apr 17, 1981
RADIOIMMUNOASSAY THYROID STIM. HORM. KIT
K810948 · JLW
Endocrine-Metabolic Center
Chemistry · 10d
Cleared Apr 17, 1981
CORNING VITAMIN B12 FOLATE DEFIC. CONTR.
K810952 · JJY
Corning Medical & Scientific
Chemistry · 10d
Cleared Apr 17, 1981
BIO SET TM SUBSTRATE CALIBRATORS
K810963 · JIS
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Apr 17, 1981
BIO SET TM PHOSPHOROUS CALIBRATOR
K810964 · JIX
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Apr 17, 1981
DATA-ZYME TRIGLYCERIDE
K810965 · CDT
Data Medical Associates, Inc.
Chemistry · 9d
Cleared Apr 14, 1981
CREATINE KINASE MB ISOENZYME IMMUNO UV
K810861 · JHW
The Dow Chemical Co.
Chemistry · 14d
Cleared Apr 14, 1981
FOLLICLE STIMULATING HORMONE (FSH)
K810867 · JIS
Pcl-Ria, Inc.
Chemistry · 14d
Cleared Apr 14, 1981
GEMENI CK-MB ISOENZYME ABNORMAL SERUM
K810870 · JJT
Gemini, Inc.
Chemistry · 14d
Cleared Apr 14, 1981
COAT-A-COUNT CORTISOL RIA KIT
K810891 · CGR
Diagnostic Products Corp.
Chemistry · 12d
Cleared Apr 14, 1981
ISOMUNE-CK
K810905 · JHW
Hoffmann-La Roche, Inc.
Chemistry · 11d
Cleared Apr 14, 1981
TRI-LEVEL NDI CONTROL
K810906 · JJY
Nuclear Diagnostics, Inc.
Chemistry · 11d
Cleared Apr 14, 1981
KOVA TROL I HUMAN URINE (DRIED)
K810917 · JJW
Icl Scientific
Chemistry · 8d
Cleared Apr 08, 1981
THERMAL PRINTER PAPER
K810549 · JJE
Nobel Scientific Industries, Inc.
Chemistry · 37d
Cleared Apr 08, 1981
SILVER ANODE
K810550 · JFS
Nobel Scientific Industries, Inc.
Chemistry · 37d
Cleared Apr 08, 1981
ACRODISC
K810829 · JRL
Gelman Sciences, Inc.
Chemistry · 14d
Cleared Apr 08, 1981
SORVALL RT6000 REFRIGERATED TABLETOP
K810833 · JQC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 14d
Cleared Apr 08, 1981
FOLLICLE STIMULATING HORMONE ANTISERUM
K810852 · CGJ
Pcl-Ria, Inc.
Chemistry · 9d
Cleared Apr 08, 1981
T3 UPTAKE KIT
K810857 · KHQ
Immuno Assay Corp.
Chemistry · 9d
Cleared Apr 07, 1981
TECHNICON STAR SYSTEM T3 RIA METHOD
K810798 · CDP
Technicon Instruments Corp.
Chemistry · 15d
Cleared Apr 07, 1981
T4 RIA KIT
K810811 · CDX
Immuno Assay Corp.
Chemistry · 14d
Cleared Apr 03, 1981
API TURBICITY STANDARD
K810762 · JKP
Analytical Products, Inc.
Chemistry · 11d