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.

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

Filters: Cleared only ×
175,230 results
149185–149208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1985
0.85% SALINE
K850845 · PPM
Micro Media Laboratories
Pathology · 19d
Cleared Mar 20, 1985
SALT BROTH
K850846 · JSJ
Micro Media Laboratories
Microbiology · 19d
Cleared Mar 20, 1985
THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN
K850847 · JSG
Micro Media Laboratories
Microbiology · 19d
Cleared Mar 20, 1985
BRAIN HEART INFUSION AGAR
K850848 · JSG
Micro Media Laboratories
Microbiology · 19d
Cleared Mar 20, 1985
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
K850883 · HOZ
Storz Instrument Co.
Ophthalmic · 16d
Cleared Mar 20, 1985
DATA ZYME ACID PHOSPHATASE PROCEDURE
K850902 · CKB
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Mar 20, 1985
CR-39 TYPE RESIN
K850905 · HQG
Orplex Corp.
Ophthalmic · 15d
Cleared Mar 20, 1985
BUN (RATE) REAGENT
K850923 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Mar 19, 1985
SERALYZER ARIS PHENYTOIN REAGENT STRIPS
K842092 · DIP
Miles Laboratories, Inc.
Toxicology · 299d
Cleared Mar 19, 1985
ACCULEVEL THEOPHYLLINE TEST
K844642 · KLS
Syva Co.
Immunology · 111d
Cleared Mar 19, 1985
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
K844955 · CEM
Miles Laboratories, Inc.
Chemistry · 88d
Cleared Mar 19, 1985
ABBOTT INPERSOL CYCLER 1000
K845042 · FKX
Abbott Laboratories
Gastroenterology & Urology · 81d
Cleared Mar 19, 1985
CLOSED WOUND DRAIN
K850037 · GCY
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 71d
Cleared Mar 19, 1985
IVAC KEOFEED II POLYURETHANE FEEDING TUBE
K850182 · KNT
Y
Gastroenterology & Urology · 60d
Cleared Mar 19, 1985
GLUTAMYLTRANSFERASE ASSAY KIT
K850788 · JPZ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 21d
Cleared Mar 18, 1985
SILICONE
K844377
Treace Medical, Inc.
General & Plastic Surgery · 125d
Cleared Mar 18, 1985
OIL, MINERAL
K844378
Treace Medical, Inc.
General & Plastic Surgery · 125d
Cleared Mar 18, 1985
MENSINK-GOOSEN CATHETER
K844889 · GBP
Goosen Enterprises, Inc.
General & Plastic Surgery · 91d
Cleared Mar 18, 1985
PERIMETER CLOSED WOUND RESEVOIR
K844921 · GCY
Perimeter Medical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 18, 1985
PERIMETER THORACIC CATHETER
K844922 · GBX
Perimeter Medical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 18, 1985
PERIMETER SUMP DRAIN
K844923
Perimeter Medical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 18, 1985
PERIMETER YANKAUER SUCTION TIPS & SETS
K844924
Perimeter Medical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 18, 1985
PERIMETER MEDIASTINAL DRAIN
K844925
Perimeter Medical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 18, 1985
WEILL CEMENTLESS THREADED ACETABULAR CUP
K844943 · KWA
Advanced Biosearch Assn.
Orthopedic · 88d